A Randomized Controlled Trial of Blood Flow Restriction Combined with Functional Training on Activities of Daily Living, Balance, and Gait Stability in Patients with Parkinson's Disease

Start Date30 Sep 2025

Sponsor / Collaborator

Tianjin University of Sport

[+1]

ChiCTR2500103341

/ Not yet recruitingNot ApplicableIIT

A Study on Changes in Copeptin and Blood Metabolites in Healthy Adults Before and After Water Loading, Oral Levodopa Intake, and Water Deprivation

Start Date01 Jun 2025

Sponsor / Collaborator-

NCT06626152

/ RecruitingPhase 2IIT

Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial

Background
Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression (LLD), a condition that usually decreases a person's quality of life and is associated with other risks like physical frailty and dementia. A common feature of more severe LLD is psychomotor slowing, where a person's ability to think and move are impaired. For example, they might not be able to walk or process information as quickly, and they might have problems with their working memory.
Psychomotor slowing in LLD might be the result of a problem with the way a person's body produces or responds to the neurotransmitter dopamine. The drug Levodopa (L-DOPA), which can replace missing dopamine in the brain, has been used to treat to treat Parkinson's disease for many decades, and it might also affect psychomotor slowing in LLD.
Methods
In this study, participants are adults aged 60 years or older with moderate to severe major depression. Participants undergo the "L-DOPA challenge"-a 2-week period where they receive a dose of L-DOPA once a day for the first week and a dose of L-DOPA twice a day for the second week. Before and after a participant completes the L-DOPA challenge, the study team assesses their depressive symptoms and psychomotor function. After the L-DOPA challenge, if a participant still shows signs of moderate or severe depression, they receive an antidepressant for 12 weeks.
Aims
The first aim of this study is to test the feasibility of the L-DOPA challenge-that is, whether most of the 50 participants recruited for this study will complete the L-DOPA challenge. For example, participants might have to withdraw if they can't make the daily visits to the research site to receive their L-DOPA medication, if they can't tolerate the medication's side effects, or if their depressive symptoms get significantly worse. Our hypothesis is that 80% of the participants will complete the L-DOPA challenge.
The second aim of the study is to see if L-DOPA affects participants' depressive symptoms, processing speed, and working memory. Our hypothesis is that L-DOPA response, measured as an improvement in gait speed, is associated with a decrease in depressive symptoms and an increase in processing speed and working memory.

Start Date15 Aug 2024

Sponsor / Collaborator

University of British Columbia

[+1]

100 Clinical Results associated with Levodopa hydrate

100 Translational Medicine associated with Levodopa hydrate

100 Patents (Medical) associated with Levodopa hydrate

33,239

Literatures (Medical) associated with Levodopa hydrate

01 Apr 2026·DEN open

Patient Characteristics and Outcomes of Endoscopically Placed Dedicated Transgastric Jejunal Tubes Compared to Percutaneous Endoscopic Gastrostomy With Jejunal Extension Tubes

Article

Author: Coelho‐Prabhu, Nayantara ; Abou Zeid, Hadi ; Kek, Laura D. ; Harmsen, William S. ; Buttar, Navtej S. ; Wong Kee Song, Louis M. ; Bruining, David H. ; Storm, Andrew C.

ABSTRACT:

Objectives:

Patients requiring long‐term enteral nutrition or continuous infusion of carbidopa/levodopa can benefit from jejunostomy tube placement. Recently, directly placed percutaneous transgastric jejunal tubes (TGJs) have been used instead of gastrostomy tubes with jejunal extensions (PEG‐Js) for enteral access. We aim to compare patient characteristics and outcomes after placement of TGJs placed via the introducer technique compared to PEG‐Js.

Methods:

We performed a retrospective study of 141 patients (TGJ = 58, PEG‐J = 83) assessed at Mayo Clinic between 2010 and 2024. Patients were identified using a prospectively maintained procedure data registry. Demographic data, patient characteristics, procedural indications, complications, and first‐replacement date were gathered. Statistical analysis included the Wilcoxon rank sum test, chi‐square test, Fisher's exact test, and Kaplan‐Meier estimates. Patients receiving carbidopa/levodopa were excluded from complications analysis due to the carbidopa/levodopa tube's proprietary structure. A p‐value of <0.05 was set as a threshold for significance.

Results:

Our results demonstrated no difference in cumulative incidence of complications within 1 year for TGJs and PEG‐Js, p‐value 0.48. Regarding time to first replacement, treating death as a competing risk factor, there was no statistically significant difference in cumulative incidence of replacement within 1 year for TGJs and PEG‐Js, p‐value 0.389.

Conclusions:

Our study demonstrates that both direct TGJs and PEG‐Js are safe options for long‐term jejunal feeding. More studies are needed to compare endoscopic to radiologically placed percutaneous transgastric jejunal feeding tubes.

01 Mar 2026·Synthetic and Systems Biotechnology

Efficient synthesis of l-DOPA in Escherichia coli via cofactor and enzyme engineering

Article

Author: Zhou, Jingwen ; Deng, Lihao ; Shan, Xiaoyu ; Linghu, Kai ; Liu, Zhuoyuan ; Zeng, Weizhu ; Zhang, Heng ; Ping, Jurong ; Li, Jianghua

The global incidence of Parkinson's disease continues to rise. Levodopa (l-DOPA) is the core therapeutic drug, and efficient and sustainable production methods are needed. However, the complex metabolic pathways and the low catalytic efficiency of enzymes limit biosynthesis of l-DOPA in microorganisms. To address this issue, this study significantly enhanced the production efficiency of l-DOPA through a multi-dimensional, integrated metabolic and enzyme engineering approach. Firstly, the de novo synthesis pathway for l-DOPA was established through optimization of the promoter, ribosome-binding site (RBS), plasmid copy number, and tighly accurately regulating the expression level of key enzymes. Secondly, combined with metabonomic analysis, carbon metabolic flow was diverted, increasing the l-DOPA titer by 36.7 %. Glucose dehydrogenase (BmgdH) and gluconate kinase (gntK) were introduced to construct a cofactor regeneration system, which synergistically enhanced the supply of NADH and FADH₂, increasing the l-DOPA conversion rate by 18 %. Next, the substrate tunnel of 4-hydroxyphenylacetic acid-3-monooxygenase subunit B (HpaB) was subjected to rational design, and mutant T292A significantly expanded the substrate channel, improved catalytic efficiency, and decreased l-tyrosine by 87 %. Finally, through the process optimization in a 5 L bioreactor (involving phased pH control and induction timing adjustment) achieved an l-DOPA titer of 60.73 g/L, the highest reported to date for de novo microbial synthesis. This research offers a novel approach for industrial biosynthesis of l-DOPA, and broadens engineering concepts for efficient synthesis of aromatic compounds.

01 Jan 2026·EXPERIMENTAL NEUROLOGY

Optimizing L-DOPA treatment through treadmill controlled exercise in a hemi-parkinsonian rat model

Article

Author: Shah, Aizza ; Budrow, Carla ; Bishop, Christopher ; McManus, Grace ; Kinzonzi, N'Senga ; Franks, Justin ; Galfano, Ashley ; Venkatesh, Shruti ; Valle, Ethan ; Lipari, Natalie ; Holden, Hannah

Parkinson's Disease (PD) is a movement disorder characterized by the loss of nigrostriatal dopamine (DA) neurons. Early-stage PD motor symptoms are typically controlled with the DA replacement therapy, levodopa (L-DOPA). However, chronic use of this treatment causes abnormal involuntary movements (AIMs) called L-DOPA-induced dyskinesia (LID). Accumulating research suggests that exercise can modify the course of PD by modulating DA signaling, thereby improving movement, and thus may also slow LID progression. This study evaluated these phenomena in hemiparkinsonian rats that display severe unilateral DA loss. Sprague-Dawley rats received unilateral 6-hydroxydopamine (6-OHDA) lesions of the left medial forebrain bundle and were then counterbalanced into equally lesioned exercise or sedentary groups. Thereafter, rats underwent 3 weeks of treadmill exercise or exposure, respectively. One-hour post-treadmill, all animals received a 4 mg/kg subcutaneous (s.c.) injection of L-DOPA. All rats were rated weekly for LID using the AIMs test. Rotarod performance was conducted 24 h before or following AIMs. Following the 4-week exercise regimen, forepaw adjusting steps (FAS) and rotarod were conducted 60 min after L-DOPA to assess group differences in L-DOPA efficacy. Results revealed lesion-induced decrements in motor performance were significantly better within exercised subjects after L-DOPA treatment. Moreover, exercise reduced the severity of LID. Post-mortem analyses showed severe DA loss in the nigrostriatal pathway of both groups while 5-HIAA, 5-HT and DA turnover were significantly higher in the lesioned striatum (STR) of exercised animals. Thus, treadmill exercise optimized L-DOPA while reducing LID. Although exercise may not restore DA in cases of severe loss, enhanced functional compensation may support its benefits when paired with DA replacement therapy.

506

News (Medical) associated with Levodopa hydrate

24 Nov 2025

·www.globenewswire.com

Cerevance to Highlight Potential of Solengepras in Parkinson’s Disease at the 2025 Parkinson Study Group Annual Meeting

New findings from Phase 2 adjunctive study evaluating the characteristics of OFF time improvement with solengepras, a novel, non-dopaminergic GPR6 inhibitor; poster selected as one of 10 featured selections for the Poster TourResults from Phase 2 ASCEND trial of solengepras as a monotherapy treatment for patients with early-stage Parkinson’s disease to be presented BOSTON, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Cerevance, a clinical-stage biopharmaceutical company advancing targeted therapies for neurodegenerative diseases and obesity, today announced upcoming presentations at the 2025 Parkinson Study Group (PSG) Annual Meeting being held from December 4-6 in San Diego. Details of the poster presentations at the 2025 PSG Annual Meeting are as follows: Title: Characteristics of OFF Time Improvement in a Phase 2 Study for Parkinson’s Disease (PD) with Solengepras, a Novel GPR6-inhibitor Presenter: Harini Sarva, M.D., Associate Professor of Clinical Neurology, Weill Cornell MedicineDate/Time: Friday, December 5, 2025, 6:15 p.m. – 7:30 p.m. PT Title: Solengepras: An Investigational Therapy with Potential Benefits on Functional and Non-Motor Measures in Early Parkinson’s Disease (PD) Presenter: Kelvin Chou, M.D., FAAN, Professor of Neurology and Co-Chief, Division of Parkinson’s Disease and Related Movement Disorders, University of Michigan Medical SchoolDate/Time: Friday, December 5, 2025, 6 p.m. – 7:30 p.m. PT In addition to the poster presentations, Cerevance CEO Craig Thompson will present updates on the company’s latest progress in Parkinson’s disease research during the PSG Industry Forum on Friday, December 5, 2025. About Solengepras (CVN424)Solengepras is designed to provide a potentially novel approach to the treatment of Parkinson’s disease. Unlike dopaminergic therapies, which primarily act by replenishing, enhancing, or mimicking dopamine, solengepras is designed to selectively address the indirect pathway by modulating the GPR6 receptor. By inhibiting GPR6, solengepras aims to restore both motor and non-motor function without directly affecting dopamine levels or signaling, improving the relative balance between the direct and indirect pathways, and potentially reducing the risk of common side effects associated with dopaminergic therapies, such as dyskinesias and motor fluctuations. Solengepras is currently being evaluated as a once-daily, oral treatment for use as an adjunctive therapy to levodopa and other anti-Parkinsonian medications in the Phase 3 ARISE trial. About CerevanceCerevance is focused on advancing cell type-specific therapies for the treatment of neurodegenerative diseases and obesity. Our proprietary platform, Nuclear Enriched Transcript Sort sequencing (NETSseq), allows us to identify targets that are expressed at very low levels, that are present in rare cell types, or that change over time as a disease progresses. Our most advanced investigational treatment, solengepras, is currently in Phase 3 development and has the potential to be a first-in-class, oral non-dopaminergic therapy for both motor and non-motor symptoms of Parkinson's disease. Our second investigational treatment, CVN293, is a highly selective investigational oral inhibitor targeting potassium two pore domain channel subfamily K member 13 (KCNK13). CVN293 represents a potentially novel intervention point for neurodegenerative disorders and obesity. For more information, please visit www.cerevance.com and follow us on LinkedIn and X. Contacts Cerevance: Johnna Simões, ir@cerevance.com Media:April Dovorany, adovorany@realchemistry.com

Phase 2Phase 3Cell TherapyClinical Result

03 Oct 2025

·www.prnewswire.com

Mitsubishi Tanabe Pharma America to Present New Data on Investigational ND0612 at the 2025 International Congress of Parkinson's Disease and Movement Disorders®

JERSEY CITY, N.J., Oct. 3, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced four poster presentations on investigational ND0612 in Parkinson's disease (PD) will be shared at the 2025 International Congress of Parkinson's Disease and Movement Disorders®, being held October 5-9 in Honolulu, HI. ND0612 is being evaluated as a 24-hour, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD). "We look forward to hearing from leading experts in the field at the meeting and discussing new data on ND0612," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "We continue to refine our understanding of the potential of ND0612 and are committed to collaborating with the greater scientific community to drive forward innovation in Parkinson's disease research." MTPA's e-posters will be presented in Exhibit Hall 1 on October 7, 12:00 – 2:30 p.m. HST. Presentation Details: Presentations will share findings from the pivotal Phase 3 BouNDless study (NCT04006210), which evaluated ND0612 vs. standard of care in people with PD experiencing motor fluctuations. The study assessed key endpoints, including ON time and OFF time, along with pharmacokinetics, efficacy across disease stages, dyskinesia and functional outcomes. Pharmacokinetic Analysis of Subcutaneous Levodopa/Carbidopa Delivery with ND0612 ( Jordan Dawson, MSL; MTPA) E-Poster #846; 12:12 p.m. HST Efficacy of ND0612 in Patients at Different Stages of Disease Severity: Subgroup-Analyses from a Randomized, Active-Controlled Study in People with Parkinson's Disease Experiencing Motor Fluctuations ( Harini Sarva, M.D, FAAN.; New York Presbyterian Hospital) E-Poster #900; 12:24 p.m. HST Dyskinesia Outcomes with ND0612 in Parkinson's Disease: Analyses from a Randomized, Active-Controlled Study ( Alberto Espay, M.D., FAAN; University of Cincinnati) E-Poster #861; 12:57 p.m. HST Reduced Falls with ND0612: Supportive Analyses From the BouNDless Phase 3 Study ( Stuart H. Isaacson, M.D., FAAN; Parkinson's Disease & Movement Disorders Center of Boca Raton) E-Poster #867; 1:42 p.m. HST About ND0612 ND0612 is an investigational drug-device combination therapy – a 24-hours/day, continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson's disease (PD). Development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC) is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness." To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to . About NeuroDerm, Ltd. NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at or follow the Company on LinkedIn. Media inquiries: [email protected] SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical Result

30 Sep 2025

·www.einpresswire.com

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

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Drug ApprovalBiosimilar

100 Deals associated with Levodopa hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D00059	Levodopa hydrate	N04BA01	DB01235

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Parkinson Disease	United States	Shire Development LLC	04 Jun 1970
Parkinson Disease	United States	Hoffmann-La Roche, Inc.	04 Jun 1970

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dyskinesias	Phase 3	United States	AbbVie, Inc.	01 Jun 2009
Dyskinesias	Phase 3	Germany	AbbVie, Inc.	01 Jun 2009
Dyskinesias	Phase 3	New Zealand	AbbVie, Inc.	01 Jun 2009
Asthma	Phase 1	United States	Acorda Therapeutics, Inc.	01 Dec 2015
Smoking	Phase 1	United States	Acorda Therapeutics, Inc.	01 Dec 2015
Autism Spectrum Disorder	Preclinical	China	Fudan University	11 Jul 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05487300 (CTgov)	Phase 2/3	Hypotension, Orthostatic \| Parkinson Disease	40	Levodopa (Testing ON Levodopa)	nlmibabhpt(pigkjaniho) = lkjaeujodc syvuffcctu (twkenfpvlj, 17.69) View more	-	05 Dec 2024
				Levodopa (Testing Off Levodopa)	nlmibabhpt(pigkjaniho) = kpjmbdfcxn syvuffcctu (twkenfpvlj, 19.88) View more
MDS2024	Not Applicable	Parkinson Disease	1,294	Continuous dopaminergic stimulation-based levodopa treatment	xosufgflfc(itrhmdbdlr): MD = -0.69 View more	Positive	27 Sep 2024
				Intermittent levodopa treatment
PD MED early disease randomisation (MDS2023)	Not Applicable	Parkinson Disease	1,593	Levodopa-sparing therapy (dopamine agonist or monoamine oxidase B inhibitor)	azaoaigmvn(zbicdpzswb): P-Value = 0.84 View more	Positive	27 Aug 2023
				Levodopa alone
NCT03761030 (CTgov)	Phase 4	Status Epilepticus \| Depressive Disorder, Major	51	L-DOPA (L-DOPA Arm)	jkrieaznau(bdnbjzuqzx) = bbdvvrtrpq bxkniuvgvi (bqcdggzjcj, 6.4) View more	-	22 May 2023
				Placebo Oral Tablet (Placebo Arm)	jkrieaznau(bdnbjzuqzx) = takjtymimw bxkniuvgvi (bqcdggzjcj, 5.8) View more
AAN2023	Not Applicable	Parkinson Disease	33	Intrajejunal Levodopa Infusion (ILI)	tgyxdytvfp(vthflasubh) = Most common complications were PEG-J tube dislodgement and pump malfunction in 18 (54.5%) patients over the study period. zqnsstzhlk (mghwkpfkqu ) View more	-	25 Apr 2023
AAN2023	Phase 3	Parkinson Disease	-	CVT-301 84mg	gslbpvfxfb(ahmvkqiyrc) = zlacsfzvkv aohcxfosap (zfscmtnkoz )	Positive	25 Apr 2023
EAN2022	Phase 2	Parkinson Disease	24	Total daily LD/CD dose of 400/100 mg 4 intakes a day every 4 hours (Q4H) plus OPC 50 mg	gflaobkonp(vpmdzwmjph) = The Q3H plus OPC regimen was also associated with an increase in LD Cmin with no significant impact on LD Cmax, leading to a ~60–90% decrease in the LD fluctuation (variation between Cmax and Cmin) xicewapjla (kgedszdzrj ) View more	Positive	24 Jun 2022
				Total daily LD/CD dose of 400/100 mg 5 intakes a day every 3 hours (Q3H) plus OPC 50 mg
CVT-301 (MDS2021)	Phase 3	Parkinson Disease	709	CVT-301 84 mg	sbvbsmdvnp(fojvyebfkw) = More patients achieved and maintained an ON state within 60 minutes postdose vs placebo pljotttzni (ugdkioguru ) View more	Positive	17 Sep 2021
				Placebo
MDS2020	Not Applicable	Parkinson Disease First line	360	Levodopa	ujcjgwgutc(oqkzekjobk) = vkadekdpvc rbouccaqtx (bblskmypdc, 3 - 15.49)	Positive	12 Sep 2020
NCT03541356 (THOR201, CTgov)	Phase 2	Parkinson Disease	32	Placebo (Placebo)	ywvddpruoo = evtlbcjiyo yvsuceftdw (mgzfrjydcd, krjjrycczx - cqfprmbwtb) View more	-	12 Aug 2020
				L-dopa 35 mg (L-dopa 35 mg)	ywvddpruoo = jhqcpgblxs yvsuceftdw (mgzfrjydcd, lbktrzjkep - fpjuxrjzue) View more

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