The goal of this clinical trial is to explore the effect of FDA-approved antiseizure drugs in the brain connectivity patterns of severe and moderate acute brain injury patients with suppression of consciousness. The main questions it aims to answer are:
Does the antiseizure medication reduce the functional connectivity of seizure networks, as identified by resting state functional MRI (rs-fMRI), within this specific target population?
What is the prevalence of seizure networks in patients from the target population, both with EEG suggestive and not suggestive of epileptogenic activity?
Participants will have a rs-fMRI and those with seizure networks will receive treatment with two antiseizure medications and a post-treatment rs-fMRI. Researchers will compare the pretreatment and post-treatment rs-fMRIs to see if there are changes in the participant's functional connectivity including seizure networks and typical resting state networks.

Start Date20 Nov 2023

Sponsor / Collaborator

The University of North Carolina at Chapel Hill

NCT03586089 / TerminatedNot ApplicableIIT

PHENObarbital for the MANagement of Severe Acute ALcohol Withdrawal Syndrome (PHENOMANAL): a Prospective Randomized Feasibility Study.

Severe acute alcohol withdrawal syndrome is a potentially life-threatening condition characterized by agitation, confusion, abnormal heart rhythms and seizures. Typically, clinicians treat the symptoms of alcohol withdrawal with a class of medications known as benzodiazepines (e.g., Valium). These medications have a short duration of activity and require repeated administration, often every hour or less, to reduce the symptoms of alcohol withdrawal. Many patients suffer complications related to inadequate treatment of alcohol withdrawal (e.g., abnormal heart rhythms, aspiration, seizures) resulting in admission to an intensive care unit and prolonged hospital stay, all of which increase healthcare costs. Although alcohol withdrawal is common, especially among disadvantaged (e.g., homeless) patients, limited funding is available to advance the care of patients suffering from alcohol withdrawal. A safe and effective treatment for severe alcohol withdrawal would benefit patients and our healthcare system.
Phenobarbital is an inexpensive, commonly available medication that is typically used to treat seizures. A key advantage of phenobarbital is that its calming effect lasts for a long period of time and it can be given as a 'one-time-dose' intravenously, so that it both prevents and treats withdrawal symptoms and reduces the need for repeated benzodiazepines. Through better symptom control, phenobarbital is expected to reduce the costs and complications of alcohol withdrawal. At present, physicians rarely use phenobarbital for this purpose, and additional research is needed for this medication to become part of routine care in clinical practice.
The PHENOMANAL pilot trial will assess safety and whether clinicians can administer a single dose of phenobarbital intravenously, in addition to benzodiazepines, compared to benzodiazepines alone for treating patients with severe alcohol withdrawal. This information will inform the design of a larger clinical trial. For patients, the PHENOMANAL trial has the potential to revolutionize how patients suffering from severe alcohol withdrawal are treated. For society and the healthcare system, phenobarbital is expected to reduce the complications and costs associated with severe alcohol withdrawal.

Start Date11 Jun 2021

Sponsor / Collaborator

Unity Health Toronto

NCT04320940 / TerminatedPhase 3

A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure. As neonatal seizures can have long-term adverse effects, including death, placebo-controlled studies are not appropriate for this population. This study is designed to show intravenous phenobarbital is effective at preventing subsequent seizures by demonstrating greater efficacy at a higher dose compared to a lower dose.

Start Date12 Mar 2021

Sponsor / Collaborator

NEMA Research, Inc.

100 Clinical Results associated with Phenobarbital Sodium

100 Translational Medicine associated with Phenobarbital Sodium

100 Patents (Medical) associated with Phenobarbital Sodium

546

Literatures (Medical) associated with Phenobarbital Sodium

01 Nov 2024·JOURNAL OF APPLIED TOXICOLOGY

Hepatic enzyme induction and its potential effect on thyroid hormone metabolism in the metamorphosing tadpole of Xenopus laevis (African clawed frog)

Article

Author: Fujisawa, Takuo ; Tanaka, Hitoshi ; Wada, Kohei ; Yamaguchi, Takafumi

Abstract:

Hepatic enzyme induction, an inherent defense system against xenobiotics, is known to simultaneously affect endocrine system functions in mammals under specific conditions, particularly thyroid hormone (TH) regulation. While this phenomenon has been studied extensively, the pathway leading to this indirect thyroid effect in mammals has unclear applicability to amphibians, despite the importance of amphibian species in assessing thyroid‐disruptive chemicals. Here, we investigated the effects of three well‐known mammalian enzyme inducers—β‐naphthoflavone (BNF), pregnenolone carbonitrile (PCN), and sodium phenobarbital (NaPB)—on the gene expression of phase‐I and phase‐II metabolizing enzymes in Xenopus laevis tadpoles. Waterborne exposure to BNF and PCN significantly induced the expression of both phase‐I (cytochrome P450, CYP) and phase‐II enzymes (UDP‐glucuronosyltransferase, UGT and sulfotransferase, SULT), but in different patterns, while NaPB exposure induced CYP2B expression without affecting phase‐II enzymes in tadpoles, in contrast to mammals. Furthermore, an ex vivo hepatic enzyme activity assay confirmed that BNF treatment significantly increased phase‐II metabolic activity (glucuronidation and sulfation) toward TH. These results suggest the potential for certain mammalian enzyme inducers to influence TH clearance in X. laevis tadpoles. Our findings provide insights into the profiles of xenosensing activity and enzyme induction in amphibians, which can facilitate a better understanding of the mechanisms of indirect effects on the thyroid system via hepatic enzyme induction in nonmammalian species.

20 Aug 2024·Zhonghua lao dong wei sheng zhi ye bing za zhi = Zhonghua laodong weisheng zhiyebing zazhi = Chinese journal of industrial hygiene and occupational diseases

[A case of recurrent convulsions caused by acute sulfuryl fluoride gas poisoning].

Article

Author: Su, C H ; Zhang, Q B ; Li, Z H ; Zhang, Y G ; Wang, R

Sulfuryl fluoride is a kind of pesticide with strong permeability, convenient use at low temperature, non-corrosive and other characteristics, which can kill food pests and has strong lethality to termites. In acute sulfuryl fluoride poisoning, patients can see recurrent convulsions, epileptic electroencephalogram abnormalities such as matrix spikes or high amplitude spikes. In this paper, a patient with sulfuryl fluoride poisoning with convulsion-based mental system symptoms was reported, and after clinical treatment with dexamethasone and phenobarbital sodium, the patient was cured and discharged.

01 Jul 2024·Biomaterials

Optical controlled and nuclear targeted CECR2 competitor to downregulate CSF-1 for metastatic breast cancer immunotherapy

Article

Author: Chen, Ying ; Yan, Mengyi ; Cheng, Hong ; Cen, Yi ; Li, Shiying ; Yan, Ni ; Chen, Xiayun ; Li, Xinxuan ; Yu, Baixue

The crosstalk between breast cancer cells and tumor associated macrophages (TAMs) greatly contributes to tumor progression and immunosuppression. In this work, cat eye syndrome chromosome region candidate 2 (CECR2) is identified to overexpress in breast cancer patients, which can recognize v-rel avian reticuloendotheliosis viral oncogene homolog A (RelA) and activate nuclear factor κB (NF-κB) to release colony stimulating factor-1 (CSF-1). Pharmacological inhibition of CECR2 by the bromodomain competitor (Bromosporine, Bro) can downregulate CSF-1 to inhibit M2 type TAMs. To amplify the immunotherapeutic effect, a chimeric peptide-based and optical controlled CECR2 competitor (designated as N-PB) is constructed to enhance the nuclear targeted delivery of Bro and initiate an immunogenic cell death (ICD). In vivo results indicate a favorable breast cancer targeting ability and primary tumor suppression effect of N-PB under optical irradiation. Importantly, N-PB downregulates CSF-1 by competitive inhibition of CECR2 and NF-κB(RelA) interactions, thus inhibiting immunosuppressive M2-like TAMs while improving the antitumorigenic M1-like phenotype. Ultimately, the systemic anti-tumor immunity is activated to suppress the metastatic breast cancer in an optical controlled manner. This study provides a promising therapeutic target and reliable strategy for metastatic breast cancer treatment by interrupting immunosuppressive crosstalk between tumor cells and macrophages.

News (Medical) associated with Phenobarbital Sodium

19 Sep 2023

·www.outsourcing-pharma.com

Pharmanovia acquires 11 of Sanofi's CNS brands expanding its global reach

Spanning four therapy areas – psycholeptic, anxiolytic, anti-epileptic and anti-psychotic, the brands fall within the unmet ongoing needs sector associated with CNS disorders. Clobazam is from a class of drug called benzodiazepines and can be used to treat anxiety, with or without insomnia or certain psychiatric conditions, in certain patients. The acquired brands include Frisium, Sentil, Urbanyl, Urbanil, Urbanol, Urbadan, Noiafren and Castilium. Frisium may also be used as adjunctive therapy in epilepsy. Phenobarbital with the brand name Gardenal is used as an anti-convulsant to treat all forms of epilepsy except absence seizures. Cyamemazine (brand name Tercian) is used to treat certain types of psychotic conditions, anxiety in patients where other treatments have failed and also some types of depression in combination with another anti-depressant. Prochlorperazine (brand name Stemetil) is used to treat vertigo, and nausea and vomiting due to various causes. It may also be used for other conditions such as schizophrenia, acute mania and as an adjunct to the short-term management of anxiety. Dr James Burt, Pharmanovia CEO, said: “Sanofi’s decision to divest this established CNS portfolio, with leading brands such as Frisium and Gardenal, to Pharmanovia is recognition of our neurology expertise, our capabilities in lifecycle management and reputation of being a trusted divestment partner. “We’re excited to use this knowledge and our global platform to ensure these important medicines not only continue to be available to the millions of patients who need them, but - through our lifecycle management - continue to evolve to meet patient needs. googletag.cmd.push(function () { googletag.display('text-ad1'); }); “Through this acquisition, we are not only building depth in geography, but we’re also bringing in products that have a clear synergy with our existing portfolio and the core sub-therapy focuses of mental health and epilepsy, where there continues to be significant unmet need.” It should be noted that not all of the acquired treatments have been approved in every market and local indications can be checked, for example, Tercian is currently only available in France. Pharmanovia is listed as a lifecycle management healthcare company and focuses on making medicines to improve the lives of patients globally. The company says this is achieved through enhancing already established medicines by ‘rediscovering, repurposing or re-engineering iconic brands to improve patient outcomes and experiences both through in-house development and strategic partnerships.’ Sanofi says it is dedicated to transforming the practice of medicine ‘by working to turn the impossible into the possible’. It aims to provide potentially life-changing treatment options and life-saving vaccine protection to millions of people around the world.

AcquisitionDrug Approval

18 Sep 2023

·www.biospace.com

Pharmanovia Acquires Global Central Nervous System (CNS) Portfolio From Sanofi

Deal sees Pharmanovia acquire 11 brands within CNS, including Frisium® (clobazam) and Gardenal® (phenobarbital) Portfolio available in 60+ markets and deepens our CNS footprint in Brazil, South Africa, France and Italy Strong CNS franchise fits with Pharmanovia’s existing neurology portfolio and commercial capabilities BASILDON, England--(BUSINESS WIRE)-- PRESS RELEASE – FOR TRADE, BUSINESS AND MEDICAL MEDIA ONLY This press release features multimedia. View the full release here: James Burt, CEO, Pharmanovia (Photo: Business Wire) Pharmanovia, a global pharmaceutical company that commercialises novel medicines and revitalises, extends and expands the lifecycle of established medicines, has today announced the expansion of its neurology portfolio with the acquisition of 11 central nervous system (CNS) brands from global healthcare company, Sanofi. The brands span four therapy areas of ongoing unmet need associated with CNS disorders - psycholeptic, anxiolytic, anti-epileptic and anti-psychotic. Clobazam is from a class of drug called benzodiazepines and can be used to treat anxiety, with or without insomnia or certain psychiatric conditions, in certain patients.1 The acquired brands include Frisium®, Sentil®, Urbanyl®, Urbanil®, Urbanol®, Urbadan®, Noiafren® and Castilium®*. Frisium® may also be used as adjunctive therapy in epilepsy.1 Phenobarbital (brand: Gardenal®*) is used as an anti-convulsant to treat all forms of epilepsy except absence seizures.2 Cyamemazine (brand: Tercian®*†) is used to treat certain types of psychotic conditions, anxiety in patients where other treatments have failed and also some types of depression in combination with another anti-depressant.3 Prochlorperazine (brand: Stemetil®*) is used to treat vertigo, and nausea and vomiting due to various causes. It may also be used for other conditions such as schizophrenia, acute mania and as an adjunct to the short-term management of anxiety.4,5 Dr James Burt, Pharmanovia CEO, commented: “Sanofi’s decision to divest this established CNS portfolio, with leading brands such as Frisium® and Gardenal®, to Pharmanovia is recognition of our neurology expertise, our capabilities in lifecycle management and reputation of being a trusted divestment partner. We’re excited to use this knowledge and our global platform to ensure these important medicines not only continue to be available to the millions of patients who need them, but - through our lifecycle management - continue to evolve to meet patient needs.” “Through this acquisition, we are not only building depth in geography, but we’re also bringing in products that have a clear synergy with our existing portfolio and the core sub-therapy focuses of mental health and epilepsy, where there continues to be significant unmet need.” -Ends- Notes to editors *Not all indications are approved in every market. For local indications it is advised to check the local approved label. †Tercian® is only available in France. About Pharmanovia Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally. We do this by enhancing established medicines by rediscovering, repurposing or re-engineering iconic brands to improve patient outcomes and experiences both through in-house development and strategic partnerships. Our diverse and growing team operate in over 160 countries across the globe, delivering high-quality solutions, ethically and sustainably, across our four core therapeutic areas – Endocrinology, Neurology, Cardiovascular and Oncology. For more information about Pharmanovia, please visit About Sanofi Sanofi is an innovative global healthcare company, driven by one purpose: to chase the miracles of science to improve people’s lives. Its team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. Sanofi provides potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the centre of its ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. References 1 - Frisium Summary of Product Characteristics, – last accessed 11.9.2023 2 - Phenobarbital Sodium Injection Summary of Product Characteristics, - last accessed 11.9.2023 3 - Terican Summary of Product Characteristics, – last accessed 11.9.2023 4 - Stemetil Injection Summary of Product Characteristics, - last accessed 11.9.2023 5 - Stemetil Tablets Summary of Product Characteristics, - last accessed 11.9.2023 COR2023PR00207 – Date of Preparation – 14.9.2023 View source version on businesswire.com: Contacts Alison Dyson, Director of Communications, Pharmanovia +44 7442 256310/alison.dyson@pharmanovia.com or pharmanovia@67health.co.uk Source: Pharmanovia Smart Multimedia Gallery Photo James Burt, CEO, Pharmanovia (Photo: Business Wire) Logo View this news release and multimedia online at:

Acquisition

100 Deals associated with Phenobarbital Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D00701	Phenobarbital Sodium	N03AA02	DB01174

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy, Benign Neonatal	US	Sun Pharmaceutical Industries, Inc.	17 Nov 2022
Spasms, Infantile	JP	Nobelpharma Co., Ltd.	16 Oct 2008
Hyperbilirubinemia	CN	Youhua Pharmaceutical (Leshan) Co Ltd	01 Jan 1981
Hyperbilirubinemia	CN	Grand Pharmaceutical Group	01 Jan 1981
Hyperbilirubinemia	CN	Chengdu Pharmaceutical Co. Ltd.	01 Jan 1981
Hyperbilirubinemia	CN	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Seizures	CN	Youhua Pharmaceutical (Leshan) Co Ltd	01 Jan 1981
Seizures	CN	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Seizures	CN	Grand Pharmaceutical Group	01 Jan 1981
Seizures	CN	Chengdu Pharmaceutical Co. Ltd.	01 Jan 1981
Sedation	JP	Takata Seiyaku Co., Ltd.	04 Mar 1980
Sedation	JP	Hisamitsu Pharmaceutical Co., Inc.	04 Mar 1980
Seizures, Febrile	JP	Hisamitsu Pharmaceutical Co., Inc.	04 Mar 1980
Seizures, Febrile	JP	Takata Seiyaku Co., Ltd.	04 Mar 1980
Sleep Initiation and Maintenance Disorders	JP	Takata Seiyaku Co., Ltd.	04 Mar 1980
Sleep Initiation and Maintenance Disorders	JP	Hisamitsu Pharmaceutical Co., Inc.	04 Mar 1980

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04320940 (CTgov)	Phase 3	Epilepsy, Benign Neonatal	4	Phenobarbital Sodium Injection (Phenobarbital Sodium Injection 20mg)	uasryfgbiv(pbekonrinp) = wjtiidesnz jbypuyyvyx (qykwgnwguf, vxryikvbbf - drbbhkldzh) View more	-	26 Oct 2023
				Phenobarbital Sodium Injection (Phenobarbital Sodium Injection 40mg)	uasryfgbiv(pbekonrinp) = rdaprbyfbu jbypuyyvyx (qykwgnwguf, ibboxxxevk - ttukhxtxep) View more

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