A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

Start Date27 Apr 2025

Sponsor / Collaborator

Universität Leipzig

NCT06714357

/ RecruitingPhase 2IIT

Randomized Phase 2 Study of Valproic Acid Combined With Rechallenge Anti-EGFR Based Regimen Regimens in Pretreated Patients With RAS/BRAF Wild-type Metastatic Colorectal Cancer - VICTORIA Trial

The investigators hypothesize that the epigenetic agent valproic acid improve the activity of anti-EGFR agents, prevent and revert the emergence of EGFR resistance, in a rechallenge setting.
Correlative mechanistic studies on tissue and blood samples, liquid biopsies, could identify potential biomarkers of efficacy and help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach with a personalized anti- EGFR treatment strategy.

Start Date12 Mar 2025

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Valproic Acid

100 Translational Medicine associated with Valproic Acid

100 Patents (Medical) associated with Valproic Acid

27,467

Literatures (Medical) associated with Valproic Acid

31 Dec 2025·Journal of Maternal-Fetal & Neonatal Medicine

A 10-year review of periconceptual folic acid supplementation in women with epilepsy taking antiseizure medications

Article

Author: O’Higgins, Amy ; McIntosh, Trudi ; Turner, Ciara ; Gaffney, Damon ; Hogan, Jennifer ; Germaine, Mark

BACKGROUND:

Epidemiological studies have reported that women with epilepsy who are taking antiseizure medications have an increased risk of Neural Tube Defects. Periconceptual folic acid supplementation potentially prevents two-thirds of cases. International guidelines recommend that women at increased risk of a pregnancy complicated by a Neural Tube Defect who could become pregnant should start high-dose (5 mg daily) oral folic acid at least three months before conceiving. The purpose of the study was to examine supplementation in women taking antiseizure medications who delivered a baby weighing >499 g during the ten years 2013-2022 in a large maternity hospital.

METHODS:

The hospital's computerized database contains standardized maternal clinical and sociodemographic details which were entered at the first antenatal visit in the obstetric records. The data on all women with epilepsy taking antiseizure medications was anonymized before coding.

RESULTS:

In the ten years, 75,869 women delivered a baby weighing >499 g. Of the deliveries, 632 (0.83%) were to women with epilepsy. Of these, 250 (0.33%) were taking antiseizure medications when they presented for antenatal care. The most frequently prescribed medications were lamotrigine n = 98 (33.8%) and levetiracetam n = 89 (30.7%). Monotherapy was prescribed in 211 (84.4%) women and polytherapy in 39 (15.6%). Three (1.2%) women took no folic acid before or after conception and 59 (23.6%) only took it after conception. Of the 188 (75.2%) who took folic acid before conception, 164 (65.6%) took high-dose 5 mg and 24 (9.6%) took low-dose 0.4 mg. No maternal characteristics were associated with taking high-dose folic acid before conception. Compliance with the national guidelines in the 16 women taking valproate was 30.8% compared with 76.0% for the other 234 women taking medications (p < 0.03). Compliance in the 211 women receiving monotherapy was 72.5% compared with 25.6% in the 39 women receiving polytherapy (p < 0.03).

CONCLUSIONS:

Two-thirds of women taking antiseizure medications complied with national guidelines on high-dose periconceptual folic acid supplementation. A particular concern is the suboptimal compliance in women prescribed valproate and polytherapy, which are two cohorts at higher risk of a neural tube defect. These findings need to be communicated to women with epilepsy in their reproductive years and their doctors.

KEY POINTS:

Of 75,869 women delivered over 10 years, 250 (0.33%) were on medications for epilepsy at presentation34.4% of women taking medications did not start high dose folic acid before conception23.6% of women did not start folic acid until after conceptionCompliance with recommendations was lowest in women prescribed valproate or polytherapyNo maternal characteristics were identified which were associated with suboptimal compliance.

31 Dec 2025·ANNALS OF MEDICINE

The clinicopathologic characteristics and tumor immune microenvironment of pulmonary enteric adenocarcinoma

Article

Author: Gong, Jiali ; Yang, Lan ; Lu, Hongyang ; Chen, Lingru

BACKGROUND:

Pulmonary enteric adenocarcinoma (PEAC) as a rare subtype of lung adenocarcinoma is sparsely reported. Currently, to achieve effective treatment and accurate prognosis prediction, the exploration of molecular markers is ongoing.

METHODS:

This study retrospectively enrolled 10 patients with PEAC confirmed by pathology at Zhejiang Cancer Hospital from April 2015 to July 2021. The investigation focused on their clinicopathological features and the tumor immune microenvironment. The expression of LAG-3, PD-L1, and MMR proteins was determined by immunohistochemistry in 7 patients with adequate tissue. Simultaneously, the levels and distribution of CD3, CD8A, CD45RO and PanCK in PEAC patients were measured by multiple immunohistochemical methods to explore and analyze the classification of TIME.

RESULTS:

A total of 10 patient pathologically diagnosed as PEAC, the mean age at diagnosis is 60.3 years, and 60% of them were male. The median follow-up for PFS subjects was 16.7 months (95%CI: 4.92-28.48 months). The median OS was 93.9 months (95% CI: 0-216.03 months). All the 7 patients in this study exhibited microsatellite stability (MSS), and PD-L1 expression was negative. Of the 7 patients, only one expressed LAG-3. The analysis of TIME in PEAC patients suggested 'cold tumors', meaning these patients may not benefit from immunotherapy.

CONCLUSION:

PEAC is a rare histological variant of LAUD that occurs predominantly in middle-aged and elderly males. Its morphological characteristics are similar to colorectal adenocarcinoma, and the NaspinA, TTF-1, CK7, CDX2 and CK20 are beneficial for diagnosis. In this study, PEAC patients showed low CD8⁺ T cell, CD45RO⁺ T cell and LAG-3 expression, and negative PD-L1 expression. And all patients were MMS.

01 Dec 2025·FUNCTIONAL & INTEGRATIVE GENOMICS

Combined transcriptomic and proteomic analyses reveal relevant myelin features in mice with ischemic stroke

Article

Author: He, Yi ; Liu, Xiaojia ; Wang, Qiwen ; Shen, Mei ; Wang, Wei ; Lyu, Hao ; Qian, Qiuyang ; Li, Desheng

Ischemic stroke (IS), a leading cause of global disability and mortality, is characterized by white matter damage and demyelination. Despite advances, the molecular mechanisms driving post-IS myelin pathology remain poorly understood, limiting therapeutic development. This study investigates key myelin-related genes (MRGs) and their regulatory networks to identify novel therapeutic targets. A transient middle cerebral artery occlusion (MCAO) model was established in C57BL/6 mice, with brain tissues collected at four timepoints (Sham0D, MCAO0D, MCAO7D, MCAO14D). Transcriptomic and proteomic sequencing were performed, followed by soft clustering (Mfuzz), functional enrichment (GO/KEGG), and ROC analysis to identify key MRGs. Competing endogenous RNA (ceRNA) networks were constructed, and drug prediction was conducted using the Comparative Toxicogenomics Database (CTD) and molecular docking. Expression validation was performed via qRT-PCR and Western blot. Integrated multi-omics analysis identified Wasf3 and Slc25a5 as key MRGs, enriched in mitochondrial respiration, calcium metabolism, and cytoskeletal regulation. The AUC values of the one-to-one model scores were all greater than 0.7, suggesting that Wasf3 and Slc25a5 were able to effectively discriminate between samples from different time points. A ceRNA network revealed critical interactions, including the Wasf3-mmu-miR-423-5p-H19 axis, linking apoptosis and myelin dysfunction. Drug prediction highlighted valproic acid (VPA) as a high-affinity binder for both genes (binding energies: - 4.2 and - 4.7 kcal/mol), suggesting its potential as a therapeutic candidate for IS. Experimental validation confirmed significant downregulation of Wasf3 mRNA (p < 0.01) and protein (p = 0.069) post-IS, while Slc25a5 showed no significant changes, potentially due to sample size limitations. This study establishes Wasf3 and Slc25a5 as pivotal regulators of post-IS myelin pathology and proposes VPA as a promising therapeutic candidate to enhance remyelination. The findings underscore the utility of multi-omics approaches in bridging molecular mechanisms to clinical translation, offering new strategies for IS diagnosis and treatment.

118

News (Medical) associated with Valproic Acid

08 Jul 2025

·www.investor.jnj.com

Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy With the addition of CAPLYTA® to Johnson & Johnson's robust portfolio of therapies, the Company now offers the broadest range of treatment options for adults with schizophrenia TITUSVILLE, N.J., July 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. CAPLYTA® is the newest addition to Johnson & Johnson's portfolio of schizophrenia therapies, which now offers the broadest range of oral and long-acting injectable treatment options to support each patient's individual treatment journey. "For people living with schizophrenia, relapses can be devastating as they disrupt lives, undo hard-earned treatment progress toward patients' goals, and increase the risk of hospitalization with each episode," said Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York.a "CAPLYTA® substantially lowers the chance of relapse for patients compared to placebo, which is often a major source of anxiety and suffering for them and their families." The submission is supported by positive results from a Phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal trial, which on the primary endpoint found time to relapse during the 26-week double-blind treatment phase was significantly longer in patients receiving CAPLYTA® compared to those receiving placebo (p=0.0002). Treatment with CAPLYTA® was also associated with a 63 percent reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]). The key secondary endpoint showed a significantly delayed time to all-cause discontinuation, including relapse, compared with placebo during the double-blind phase (p=0.0007). The safety profile of CAPLYTA® was consistent with the existing body of clinical data, and no new safety concerns were identified. The most commonly reported adverse event that was observed at a rate greater than or equal to 5% and twice the rate of placebo was headache.i Schizophrenia affects up to an estimated 2.8 million adults in the United States, yet it remains insufficiently treated, with approximately 40 percent of people not receiving care.ii When left untreated, this complex mental health disorder can lead to episodes of psychosis, hallucinations, or other disruptive behaviors, which can damage and interrupt the lives of those living with schizophrenia as well as their loved ones.iii Relapses, or a recurrence of symptoms, are associated with significant functional decline, increased caregiver burden, and a greater likelihood of hospitalization.iii On average, an adult with schizophrenia experiences nine relapses in less than six years.iv "Relapse prevention is a critical goal for the long-term care and management of this debilitating disorder," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "These Phase 3 results provide compelling evidence of meaningful relapse prevention, which is critical in preserving long-term patient stability, breaking the cycle of hospitalization, and helping to control symptom progression. We're committed to building on the decade of research reinforcing the robust efficacy, proven safety, and favorable tolerability of CAPLYTA® and providing additional data to support the long-term use of this medicine in neuropsychiatric disorders." While its exact mechanism of action is unknown, CAPLYTA® is characterized by high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses. In short-term clinical studies, CAPLYTA® was similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms, which are often cited as reasons for treatment discontinuation. The most commonly reported adverse events were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA® can be taken at any time of day with or without food and does not require titration, allowing adult patients to start treatment at the effective dose. CAPLYTA® is FDA approved for the treatment of schizophrenia, as well as depressive episodes associated with bipolar I or II disorder in adults, as monotherapy, and as adjunctive therapy with lithium or valproate. An sNDA for CAPLYTA® as an adjunctive treatment for adults with major depressive disorder (MDD) is currently under FDA review. If approved, CAPLYTA® has the potential to become a new standard of care to treat some of today's most prevalent and debilitating mental health disorders. Editor's note: a. Christoph U. Correll, M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work. About Schizophrenia Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the United States yet remains widely misunderstood and insufficiently treated.ii Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common. Evidence shows that the first three to five years after diagnosis – "the critical period" – from symptom onset are key for a patient's treatment, as this is when the condition progresses most rapidly.v,vi A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, can be critical in delaying the time to relapse for adults with schizophrenia.iii About Study 304This study was a multicenter, multi-national, double-blind, placebo-controlled, randomized withdrawal study of lumateperone for the prevention of symptomatic relapse in adult patients with schizophrenia. The approximately 47-week study included an 18-week open-label phase where patients with schizophrenia were treated with lumateperone 42 mg per day. Patients who met the stabilization criteria during the open-label period progressed to the double-blind treatment phase. These patients were randomized to continue on lumateperone 42 mg (N=114) or switched to placebo (N=114) for up to 26 weeks or until the time to relapse occurred. The primary endpoint was time to first symptom relapse and the key secondary endpoint was time to all cause discontinuation during the double-blind phase. About CAPLYTA® (lumateperone) CAPLYTA® 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA® is unknown, the efficacy of CAPLYTA® could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. CAPLYTA® is under FDA review for potential approval as an adjunctive treatment for adults with major depressive disorder and is being studied for other neuropsychiatric and neurological disorders. CAPLYTA® is not FDA-approved for these disorders. CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Important Safety Information Boxed Warnings: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria. Warnings & Precautions: Antipsychotic drugs have been reported to cause: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above. Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room. Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued. Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment. Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors. Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension. Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA. Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold. Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them. Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics. Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration. Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors. Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment. Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules. Please click here to see full Prescribing Information including Boxed Warnings. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. © Johnson & Johnson and its affiliates 2025. All rights reserved. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of CAPLYTA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Footnotes i Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with Schizophrenia. GlobeNewswire, 05 Nov. 2024, https://www.globenewswire.com/news-release/2024/11/05/2974784/30597/en/Intra-Cellular-Therapies-Announces-Positive-Topline-Results-in-Phase-3-Trial-Evaluating-CAPLYTA-for-the-Prevention-of-Relapse-in-Patients-with-Schizophrenia.html. ii "Schizophrenia Fact Sheet." Treatment Advocacy Center, 10 Mar. 2025, www.tac.org/reports_publications/schizophrenia-fact-sheet/. iii Alphs L, et al. Factors associated with relapse in schizophrenia despite adherence to long-acting injectable therapy. Int Clin Psychopharmacol. 2016;31(4)202-209. doi:10.1097/YIC.0000000000000125 iv Lafeuille MH, Gravel J, Lefebvre P, et al. Patterns of relapse and associated cost burden in schizophrenia patients receiving atypical antipsychotics. J Med Econ. 2013;16(11):1290-1299. doi: 10.3111/13696998.2013.841705 v Birchwood, M. "Early intervention and sustaining the management of vulnerability." The Australian and New Zealand journal of psychiatry vol. 34 Suppl (2000): S181-4. doi:10.1080/000486700241 vi Tandon, Rajiv et al. "The schizophrenia syndrome, circa 2024: What we know and how that informs its nature." Schizophrenia research vol. 264 (2024): 1-28. doi:10.1016/j.schres.2023.11.015 View original content to download multimedia:https://www.prnewswire.com/news-releases/supplemental-new-drug-application-submitted-to-us-fda-for-caplyta-lumateperone-with-data-demonstrating-significant-schizophrenia-relapse-prevention-compared-to-placebo-302499436.html SOURCE Johnson & Johnson

Clinical ResultPhase 3Drug ApprovalCell Therapy

30 Jun 2025

·www.einpresswire.com

GenBio CSO Professor Lindsay Brown Drills Down into the Autism Spectrum Disorder

The Global Burden of Disease 2021 report estimated that 1 in 127 people or 61.8 million were on the autism spectrum (ASD) globally I know of nobody who is purely autistic, or purely neurotypical. Even God has some autistic moments, which is why the planets spin.” — Jerry Newport ALISO VIEJO, CA, UNITED STATES, June 30, 2025 / EINPresswire.com / -- The Global Burden of Disease 2021 report estimated that 1 in 127 people or 61.8 million were on the autism spectrum ( ASD ) globally, leading to a burden of 11.7 million disability- adjusted life years. The non-fatal health burden of ASD as a developmental condition includes persistent difficulties in social interaction, challenges with sensory perception, and repetitive behaviours. The causes of ASD are very complex, including genetic and epigenetic changes, environmental factors such as increased maternal age, maternal characteristics of metabolic syndrome, changes in the gut microbe-brain axis, medication exposure such as the antidepressant valproic acid and the effects of infection, oxidative stress and inflammation. These causes underlie the heterogeneity in the aetiology, phenotype and outcome of ASD. Treatment for ASD mainly includes ongoing behavioural and educational interventions but there are no pharmacological interventions that target the core ASD symptoms. The gut-brain axis allows the brain to regulate gastrointestinal function while the gut microbiome regulates the brain by immune, neuroendocrine and vagal pathways. Molecules that regulate the brain derived from the gut microbiome include lipopolysaccharide, short- chain fatty acids, vitamins including the B-group, neurotransmitters such as pro-inflammatory cytokines, intestinal hormones and tryptophan metabolites such as 5-hydroxytryptamine (5-HT) and kynurenine. Enteroendocrine cells (EC) in the gut produce 95% of the body’s 5-HT; chronic exposure to the gut microbiota increases 5-HT synthesis by an increased EC proliferation. Changes to the gut microbiome may also be relevant to maternal influences on ASD. These changes are not unique to ASD but may contribute to many brain health issues including depression, anxiety and neurodegenerative disorders. Modifying gut microbiota in ASD by dietary modulation may decrease gastro-intestinal dysfunction and improve behaviour. However, eating disorders combined with tantrums and behavioural problems are common in ASD children so dietary modulation will not always be feasible. The importance of the gut microbiota is shown by Microbiota Transfer Treatment as a potential therapy for ASD; in 18 children, follow-up after 2 years showed that improvements in gastro-intestinal symptoms were maintained while further improvements in autism-related symptoms were measured. Prebiotics and synbiotics may produce improvements for some behavioural and gastrointestinal symptoms in ASD but the evidence should be expanded. Further, there is evidence for benefits of probiotics in children with ASD showing behavioural and gastrointestinal improvements. Dietary nutraceuticals include the anthocyanins as the purple, red and blue colours in many fruits, including Queen Garnet and Davidson’s plums. The anthocyanins produce anti- inflammatory and antioxidant responses and change the gut microbiome. Treatment with an anthocyanin-containing extract from blueberries decreased neuroinflammation and gut inflammation, modulated the gut microbiota and improved 5-HT concentrations in the gut and prefrontal cortex to ameliorate autism-like behaviours in a valproic acid mouse model of autism. Clinical trials of anthocyanins in patients with cognitive impairment in mild Alzheimer’s disease have shown improved vascular responses. While these limited clinical trials with anthocyanins in mental health issues are important, they need to be extended to long-term but expensive trials as part of treatment for ASD patients. There are many changes that could improve life outcomes for autistic people and further research on chronic interventions with anthocyanins during pregnancy and in childhood would seem to be justified. Todd D. Sonoga GenBio Inc. +1 949-705-8021 email us here Visit us on social media: LinkedIn Facebook X GenBio Inc Elevator Pitch Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Microbial therapyClinical Study

19 Jun 2025

·www.businesswire.com

Lundbeck Advances Leadership in Migraine With New Data at the American Headache Society 67th Annual Scientific Meeting

DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck US, the US subsidiaries of H. Lundbeck A/S, today announced it will present one oral and eight poster presentations at the 67th Annual Scientific Meeting of the American Headache Society (AHS) in Minneapolis from June 19-22, 2025. The data presentations reinforce the need to look beyond monthly migraine days (MMDs) and the importance of a holistic approach to migraine care as suggested by data from eptinezumab-jjmr post-hoc analyses. VYEPTI® (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of its ingredients. Reactions have included anaphylaxis and angioedema. Please see Important Safety Information below. “Migraine disease affects over 40 million people in the U.S.,1 profoundly impacting every aspect of life for many,” said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. “Lundbeck is energized to be at AHS, driving conversations on how we can better understand the holistic burden of migraine and redefine how we approach care. Our focus goes beyond just alleviating individual symptoms—we are committed to improving the overall quality of life for people living with migraine disease.” Analyses presented at AHS from several studies including clinical trials and real-world research continue to focus on novel ways to assess VYEPTI and study results and advance preventive migraine care: P-341 : Eptinezumab Treatment was Associated with Longer Interictal Periods and Corresponding Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial: Individuals living with migraine who have longer periods of time between migraine attacks (interictal periods) may experience a reduced overall burden of migraine. A post-hoc analysis of the phase 3b DELIVER trial during weeks 1-12 (n=853) and weeks 1-24 (n=832) evaluated the association between the mean longest interictal period and improvements in patient-reported quality of life (QoL) outcomes. Results from this post-hoc analysis indicate the mean longest interictal period was larger with VYEPTI than as reported by patients receiving placebo during the first 24 weeks of the DELIVER trial. Among participants with >14- and >21-day mean longest interictal periods, a greater proportion of participants achieved clinically meaningful improvements in the 6-item Headache Impact test score (HIT-6; ≥5-point total score reduction) and Patient Global Impression of Change (PGIC; “much improved” or “very much improved” rating) with VYEPTI compared with placebo. 2 P-333 : Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention : Researchers analyzed select phase 3 clinical trials to assess retention rates for adult participants who were treated with VYEPTI and other anti-CGRP mAbs for the prevention of migraine, including long-term eptinezumab trials: the 104-week, open label, single-arm PREVAIL trial and the 72-week DELIVER trial. In this retrospective cohort study of US claims data, VYEPTI showed high, long-term retention rates for preventive treatment in participants with chronic migraine and in those with migraine for whom 2-4 prior migraine preventive treatments have failed, suggesting a high level of participant satisfaction with continued treatment of VYEPTI. Similar results were observed in other anti-CGRP mAbs in this treatment group. 3 P-332 : Baseline Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive Anti-CGRP Treatment Had Failed: Interim Results of an Ongoing Real-World Study : INFUSE is an ongoing, non-interventional, prospective study in individuals with migraine initiating VYEPTI for the preventive treatment of migraine. In an interim analysis of the first 75 participants entering the INFUSE study, results indicate that individuals, despite having ≥1 prior a-CGRP preventive treatment, reported a long history of disease and high disease burden (with regard to frequency, severity and cognitive impairments). Interim results also showed that the level of concern about initiating an intravenous (IV) treatment was low and participants in the study generally had a positive infusion experience. 4 Further highlighting our commitment to pushing the boundaries on migraine care with preventive treatments, Lundbeck also will host a symposium titled, “Why the interictal period matters: Striving for migraine freedom” with Dr. Amaal Starling and Dr. Stewart Tepper on Thursday, June 19 from 12:30 p.m. to 1:15 p.m. CT. “For optimal migraine management, it’s important to prioritize continuous improvement and a patient-centered approach,” said Dr. Amaal Starling, Neurologist, Mayo Clinic. “These studies highlight the real-world impact of preventive migraine treatments that can provide sustained control, which may allow individuals to focus on their personal goals and live their lives to the fullest.” Additional migraine data being presented at AHS include: IOR-02 (Oral) : Patient Perspectives of Migraine Symptomology: Insights from Exit Interviews from the anti-PACAP Antibody Phase 2 HOPE Trial for Migraine Prevention 5 P-299 : Associated Long-Term Clinical Improvements Following ≥50% Migraine Response and Sustained ≥50% and ≥75% Migraine Reductions in Early Responders to Eptinezumab Treatment in Participants With Migraine: Post Hoc Analyses of the DELIVER Trial 6 P-320 : Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post Hoc Analysis of the Phase 3 PREVAIL Study 7 P-319 : Impact of Participant-reported ≥75% Increase in Good Days/Month on Migraine Symptoms, Quality of Life, and Brain Fog: Results of the REVIEW Real-world Study of Adults With Chronic Migraine Treated with Eptinezumab 8 P-297 : Eptinezumab and Patient Education in Chronic Migraine and Medication-overuse Headache: Results from the Randomized, Placebo-controlled RESOLUTION Trial 9 P-308 : Efficacy and Safety of Eptinezumab in Chronic Migraine: A Randomized Placebo-controlled Trial in a Predominantly Asian Population 10 About VYEPTI® VYEPTI® (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. VYEPTI was deliberately developed for administration by IV infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion. The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with VYEPTI discontinued treatment due to adverse reactions. VYEPTI offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information. INDICATION VYEPTI (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy. Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. VYEPTI should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms. ADVERSE REACTIONS The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020. For more information, please see Full Prescribing Information and Patient Information or visit www.VYEPTIHCP.com. About Migraine Disease Migraine is a complex and disabling neurological disease that limits functionality and quality of life.1 It is characterized by moderate to severe head pain typically accompanied by an array of symptoms, including nausea, vomiting and sensitivity to light or sound.1,11 Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration.12,13 It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men.1 It is the second leading cause of years lived with disability (YLD) among all diseases and is the top YLD cause among people aged 15 to 49 years, according to the Global Burden of Disease study. The impact of migraine permeates into career, home life and relationships.14 About INFUSE study INFUSE is an ongoing, non-interventional, prospective study in individuals with migraine, initiating preventive treatment with eptinezumab-jjmr. Eligible participants were recruited by two infusion center networks and are being followed for 12 months after initiating eptinezumab-jjmr treatment. INFUSE includes adults ≥18 years of age with a diagnosis of migraine who tried ≥1 preventive a-CGRP treatment (erenumab, fremanezumab, galcanezumab, atogepant, or rimegepant [prescribed every other day]). About DELIVER study DELIVER (NCT04418765) is a phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of eptinezumab-jjmr in patients with chronic or episodic migraine. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days, and episodic migraine as migraine occurring on ≥4 days and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior preventive treatment classes (including: propranolol, metoprolol, topiramate, amitriptyline, flunarizine, valproate, divalproex, candesartan) or botulinum toxin A/B (if documented that botulinum toxin was used for chronic migraine), and at least one failure being due to inadequate efficacy. Patients who experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway were excluded from participation. Documented evidence of prior migraine treatment failures was supported by medical records or by physicians´ confirmation specific to each treatment in the past 10 years. In the study, 892 patients were randomized to receive eptinezumab-jjmr 100 mg or 300 mg or placebo by IV infusion. Patients included in the study most frequently experienced treatment failures of topiramate and amitriptyline, with 550(61.8%), 277(31.1%), and 60(6.7%) patients experiencing 2, 3, and 4 prior preventive treatment failures respectively. The primary endpoint was change from baseline in the number of monthly migraine days over Weeks 1-12. Key secondary endpoints included response rates as patients with 50% or greater reduction from baseline in MMDs (Weeks 1-12), response rates of patients with 75% or greater reduction from baseline in MMDs (Weeks 1-12) and change from baseline in the number of MMDs (Weeks 13-24). Other secondary endpoints assessed the effect of eptinezumab-jjmr vs placebo on: 6-item Headache Impact test score (HIT-6), Migraine-specific quality of life (MSQ v2.1), HRQoL (EQ-5D-5L) visual analogue scale (VAS) score, healthcare resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI). The safety and tolerability of eptinezumab-jjmr in the DELIVER study were similar to placebo and consistent with findings from previous eptinezumab-jjmr clinical trials. In DELIVER and earlier eptinezumab-jjmr studies, upper respiratory tract infection, nasopharyngitis, dizziness, and fatigue were the most commonly reported treatment-emergent adverse events (TEAEs). About PREVAIL study PREVAIL was a phase 3, open-label multi-site U.S.-based study that evaluated eptinezumab-jjmr 300 mg intravenous administration in 128 adults with chronic migraine (CM). PREVAIL included two treatment phases: the primary treatment phase included four infusions of eptinezumab-jjmr 12 weeks apart (Day 0, and Weeks 12, 24, and 36); the secondary treatment phase included up to four additional eptinezumab-jjmr infusions 12 weeks apart (Weeks 48, 60, 72, and 84). Further, patients were followed for 20 additional weeks after the final infusion until Week 104. The PREVAIL study evaluated the long-term safety of repeat doses of eptinezumab-jjmr 300 mg in patients with CM, as well as the pharmacokinetics, immunogenicity, and patient-reported outcomes (PROs). Patient-reported outcome measures included the Migraine Disability Assessment (MIDAS) questionnaire, patient-identified most bothersome symptom (PI-MBS) associated with migraine, Patient Global Impression of Change (PGIC), and 6-item Headache Impact Test (HIT-6). About a-PACAP a-PACAP monoclonal antibody is an investigational compound currently under development (phase 2) for the treatment of migraine. The compound is not commercially available globally. About Lundbeck Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long-term value for our shareholders by making positive contributions to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. Lundbeck US comprises the wholly owned US subsidiaries of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC) (“Lundbeck”), including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. For additional information, please visit Lundbeck.com/us and connect with us on LinkedIn and X at @LundbeckUS. References 1 Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review. Headache, 64(5), 516–532. https://doi.org/10.1111/head.14709 2 Tepper, Stewart J., Joshi, Shivang, Hirman, Joe, et al. Eptinezumab Treatment was Associated with Longer Interictal Periods and Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 3 Blumenfeld, Andrew, Patel, Foram, Kapur, Neha, et al. Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 4 Starling, Amaal, Regnier, Stephane, Soni-Brahmbhatt, Seema, et al. Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive anti-CGRP Treatment had Failed: Interim Results of an Ongoing Real-world Study. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 5 Lipton, Richard B., IOR-02 - Patient perspectives of migraine symptomology: Insights from exit interviews from the anti-PACAP antibody phase 2 HOPE trial for migraine prevention. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 6 Ailani, Jessica, Ashina, Messoud, Awad, Susanne F., et al. Long-term Improvements Following ≥50% Migraine Response to Eptinezumab Treatment in Participants With Migraine: Post Hoc Analysis of the DELIVER Trial. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 7 Starling, Amaal, Kudrow, David, Kapur, Neha, et al. Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post-Hoc Analysis of the Phase 3 PREVAIL Study. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 8 Starling, Amaal, Kudrow, David, Kapur, Neha, et al. Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post-Hoc Analysis of the Phase 3 PREVAIL Study. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 9 Jensen, Rigmor H., Lundqvist, Christofer, Schytz, Henrik W., et al. Eptinezumab and patient education in chronic migraine and medication-overuse headache: Results from the randomized, placebo-controlled RESOLUTION trial. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 13, 2025 10 Yu, Shengyuan, Matsumori, Yasuhiko, Kim, Byung-Kun, et al. Efficacy and safety of eptinezumab in chronic migraine: A randomized placebo-controlled trial in a predominantly Asian population. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 13, 2025. 11 National Institute of Neurological Disorders and Stroke. Migraine. Available at: https://www.ninds.nih.gov/health-information/disorders/migraine. Accessed March 28, 2024. 12 GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016 [published correction] appears in Lancet. 2017;390(10100):1211-1259. 13 American Headache Society. Headache. 2019; 59: 1–18. 14 Buse DC, Fanning KM, Reed ML, et al. Life With Migraine: Effects on Relationships, Career, and Finances From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2019;59(8):1286-1299. doi: https://doi.org/10.1111/head.13613.

Clinical ResultPhase 2Phase 3Drug Approval

100 Deals associated with Valproic Acid

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KEGG	Wiki	ATC	Drug Bank
D00399	Valproic Acid	N03AG01	DB00313

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Indication	Country/Location	Organization	Date
Mania	United States	Bionpharma, Inc.	29 Jul 2008
Migraine Disorders	United States	Bionpharma, Inc.	29 Jul 2008
Epilepsy	United States	AbbVie, Inc.	28 Feb 1978

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Indication	Highest Phase	Country/Location	Organization	Date
Alcoholism	Phase 3	United States	AstraZeneca PLC	01 Jan 2006
Epilepsies, Partial	Phase 3	United States	Abbott Laboratories	01 Jul 2003
Bipolar II disorder	Phase 3	Germany	AstraZeneca PLC	01 Jan 2002
Epilepsy, Temporal Lobe	Phase 2	Australia	Cerebral Therapeutics, Inc.	01 Aug 2016
Secondarily generalized seizures	Phase 2	Australia	Cerebral Therapeutics, Inc.	01 Aug 2016
Seizures	Phase 2	Australia	Cerebral Therapeutics, Inc.	01 Aug 2016
Spinal Muscular Atrophy	Phase 2	United States	Abbott Laboratories	01 Jul 2007
Contraception	Phase 1	United Kingdom	Estetra SRL	12 Apr 2018
Wounds, Nonpenetrating	Phase 1	United States	University of Michigan	01 Nov 2016
Shock, Hemorrhagic	Phase 1	United States	University of Michigan	01 Sep 2013

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03689114 (STANDLOW, CTgov)	Phase 4	Epilepsies, Partial	58	Low dose oxcarbazepine+Low dose topiramate+Low dose carbamazepine+Low dose levetiracetam+Low dose valproate+Low dose lamotrigine+Low dose zonisamide+Low dose gabapentin (Low Dose)	mupbohxumr = seiuunfuqr xcihavrvzn (kaaejmoddc, swoettutac - rssdinzrnn) View more	-	08 Jul 2025
				oxcarbazepine+topiramate+carbamazepine+levetiracetam+valproate+lamotrigine+gabapentin+zonisamide (Standard Dose)	mupbohxumr = usamjndevq xcihavrvzn (kaaejmoddc, avtnzwmznd - qoxexrvxeg) View more
NCT06248931 (Pubmed \| J Clin Neurosci)	Phase 3	Migraine Disorders	574	Valproate	nctfzsxqvz(kwiiaajwtb) = neoihtvhnt sobvjmsoxe (honcfielht )	Positive	01 May 2025
				Topiramate	nctfzsxqvz(kwiiaajwtb) = lgsqnvzgvn sobvjmsoxe (honcfielht )
CTNI-45 (SNO2024)	Phase 2	Recurrent Malignant Glioma GRP78 (HSPA5) \| PDGFRa	33	Sorafenib	pyhojzvnli(rdalhlxibj) = one grade 3 toxicity for maculopapular rash (6.4%) rpvqkojxvk (sknhpdmvlq ) View more	Positive	11 Nov 2024
NCT05821556 (VESPA, Pubmed \| BMC Cancer)	Phase 2	Pancreatic adenocarcinoma metastatic CA 19.9	240	VPA/SIM plus gemcitabine/nab-paclitaxel-based regimens	kbkuehespr(vcnagkebfj) = dsrycwbftz pfymevpwku (bgsvwqmzfy )	-	19 Sep 2024
				Chemotherapy alone	kbkuehespr(vcnagkebfj) = siqocprune pfymevpwku (bgsvwqmzfy )
CRD42022363844 (AAN2024)	Not Applicable	Seizures	18,676	Phenytoin	ukvupdscxv(zplccdmion) = fkicpzrdlk yusrupbrwz (ippjipinnt, 23.2–52.8)	Positive	09 Apr 2024
				Carbamazepine	ukvupdscxv(zplccdmion) = pklenpenpz yusrupbrwz (ippjipinnt, 1.7–5.3)
CNS2023	Phase 1/2	Migraine Disorders	17	Normal Saline, Prochlorperazine, Ketorolac	rsbaznrtel(ymbhbdpdah) = iqwxdtrbdl mphnzzuddk (dmxtquwchh ) View more	Positive	01 Oct 2023
NCMP-08 (SNO2022)	Not Applicable	Glioma	1,435	Levetiracetam + Valproic Acid + Clobazam	lqipptqipb(grjcncdxyt) = zelpszrvur agcmhrdmom (rssupjftdp, 48 - 78)	Positive	14 Nov 2022
				Other ASM Triple Therapy	lqipptqipb(grjcncdxyt) = ivcvsxhkac agcmhrdmom (rssupjftdp, 47 - 75)
NCT02068586 (ASCO2022) Manual	Phase 2	Uveal Melanoma Adjuvant	88	Sunitinib 25 mg daily	denqneirvs(xtwwrkxtue) = lgwlturusb swbtgnygth (tpsahyjtxg, 86.5 - 98.6) Met View more	Positive	02 Jun 2022
				Valproic acid 750 mg daily	denqneirvs(xtwwrkxtue) = pvvmmdplqd swbtgnygth (tpsahyjtxg, 80.1 - 95.8) Met View more
NCT01817751 (CTgov)	Phase 2	Glioblastoma \| Recurrent Malignant Glioma	47	Sildenafil Citrate+sorafenib tosylate+Valproic Acid	cltpczjolu = chhrbsyqql udopbshjap (juikrcsryp, alrsqmchst - bzqdremxsw) View more	-	28 Oct 2021
NCMP-08 (SNO2020)	Not Applicable	Epilepsy \| Glioma	64	Phenytoin	rmtbrmlqtn(wxckdxewas) = xhsdyfppxl hnoqhtcwad (elltpgqwrz )	Positive	09 Nov 2020
				Pregabalin	rmtbrmlqtn(wxckdxewas) = foxoigkmzt hnoqhtcwad (elltpgqwrz )

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