Walking with age becomes both slower and less 'automated', requiring more attention and brain resources. As a result, older adults have a greater risk of negative outcomes and falls. There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments, as there are currently no effective treatments available. Investigators have recently discovered that
20% of older adults maintain fast walking speed even in the presence of small blood vessel brain changes and leg problems, thus appearing to be protected against these harmful factors. The investigators work suggests that the brain dopamine (DA) system may be a source of this protective capacity. Investigators have also shown that lower levels of dopamine are associated with slow walking. Investigators will be investigating the role of dopamine on slow walking and other parkinsonian signs in this open-label study using detailed clinical assessment, assessment of dopamine activity, and clinical interventions.

Start Date29 Oct 2024

Sponsor / Collaborator

University of Michigan

[+1]

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]

NCT06219915

/ CompletedPhase 1/2IIT

Neurobiological Drivers of Mobility Resilience: The Dopaminergic System

Walking with age becomes both slower and less 'automated', requiring more attention and brain resources. As a result, older adults have a greater risk of negative outcomes and falls. There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments, as there are currently no effective treatments available. Investigators have recently discovered that
20% of older adults maintain fast walking speed even in the presence of small blood vessel brain changes and leg problems, thus appearing to be protected against these harmful factors. The investigators work suggests that the brain dopamine (DA) system may be a source of this protective capacity. Investigators have also shown that lower levels of dopamine are associated with slow walking. Investigators will be investigating the role of dopamine on slow walking and other parkinsonian signs in this double-blinded, placebo-controlled study using detailed clinical assessment, assessment of dopamine activity, and clinical interventions.

Start Date15 Mar 2024

Sponsor / Collaborator

University of Michigan

[+1]

100 Clinical Results associated with Carbidopa

100 Translational Medicine associated with Carbidopa

100 Patents (Medical) associated with Carbidopa

3,646

Literatures (Medical) associated with Carbidopa

01 Apr 2025·The Neurohospitalist

Acute Ischemic Stroke Presenting as Hemiparkinsonism: A Case Report

Article

Author: Al-Sibahee, Essam ; Al-Obaidi, Mustafa Najah ; Al-Sharee, Asmaa

Parkinsonism, commonly associated with Parkinson disease (PD), can also arise from other neurodegenerative disorders or non-neurodegenerative causes such as vascular parkinsonism (VP). This case highlights the acute onset of VP following a stroke, contributing to the understanding of VP’s varied presentations and the challenges in its diagnosis. A 54-year-old male with a history of cerebrovascular disease presented with behavioral changes and reduced activity, initially raising the suspicion of a central nervous system infection. Clinical findings included agitation, decreased social interaction, mutism, drooling, immobility, and rigidity. Imaging revealed acute infarction in the left cortical parieto-occipital region, caudate nucleus, and putamen, along with old infarcts, confirming VP. The primary diagnosis was vascular parkinsonism and he was started on anticoagulation therapy and levodopa/carbidopa, which showed minimal improvement over 6 months. This case underscores the importance of considering VP in patients with acute parkinsonian symptoms and a history of cerebrovascular disease. It highlights the necessity for prompt evaluation and management of vascular risk factors to optimize patient outcomes. Additionally, it emphasizes the need for a multidisciplinary approach in treating VP, given the limited efficacy of traditional Parkinson disease medications.

04 Mar 2025·Expert Opinion on Drug Metabolism & Toxicology

Clinical pharmacokinetics of levodopa and relevant add-on therapies for Parkinson’s disease

Review

Author: Müller, Thomas

INTRODUCTIONParkinson's disease is a chronic neurodegenerative disease entity characterized by heterogeneity of symptoms and progression. Levodopa is an efficacious and well tolerated dopamine substituting drug for its therapy. Its O-methylation and generation of 3-O-methyldopa is enhanced by levodopa/dopa decarboxylase inhibitor formulations. Additional inhibition of catechol-O-methyltransferase is the relevant add on therapy for levodopa application. This pharmacologic approach increases the plasma appearance of levodopa and reduces 3-O-methyldopa synthesis. Available marketed compounds are entacapone, tolcapone and opicapone. Data on their effects on levodopa pharmacokinetics in patients are rare.AREAS COVEREDThis review describes the impact of this add-on therapy on the pharmacokinetic profile of levodopa and 3-O-methyldopa in plasma. The rationale was to perform a comparison with data from previously published pharmacokinetic trials with a standardized one time intake of levodopa/carbidopa without and with the available catechol-O-methyltransferase inhibitors.EXPERT OPINIONResults of this analysis identified opicapone as the most efficacious inhibitor of catechol-O-methyltransferase in terms of changes of levodopa plasma concentrations. Opicapone induced higher levodopa plasma levels compared with the ones following application of levodopa/carbidopa alone or combined with entacapone or tolcapone. Co-administration of opicapone with its once daily intake regimen may support the efficacy of subcutaneous and intrajejunal levodopa infusions.

01 Mar 2025·Brain, Behavior, and Immunity

Sustained effects of repeated levodopa (L-DOPA) administration on reward circuitry, effort-based motivation, and anhedonia in depressed patients with higher inflammation

Article

Author: Miller, Andrew H ; Ashchi, Andrea ; Bekhbat, Mandakh ; Dunlop, Boadie W ; Goldsmith, David R ; Treadway, Michael T ; Felger, Jennifer C ; Li, Zhihao ; Revill, Kate P ; Wommack, Evanthia C ; Hong, Changdo ; Lucido, Michael J ; Haroon, Ebrahim ; Mehta, Neeti D

Inflammatory biomarkers like C-reactive protein (CRP) are elevated in a subset of patients with depression and have been associated with lower functional connectivity (FC) in a ventral striatum (VS) to ventromedial prefrontal cortex (vmPFC) reward circuit and symptoms of anhedonia. Evidence linking these relationships to the effects of inflammation on dopamine is consistent with our recent findings that acute levodopa (L-DOPA) increased VS-vmPFC FC in association with deceased anhedonia in depressed patients with higher but not lower CRP (>2 versus ≤ 2 mg/L). To determine whether repeated L-DOPA administration caused sustained effects on FC and behavior in these patients, medically stable depressed outpatients with CRP > 2 mg/L and anhedonia (n = 18) received one week of three doses of L-DOPA (150-450 mg/day/week with carbidopa) or placebo in a randomized order. Resting-state (rs) and task-based (tb; monetary incentive delay) fMRI, effort-based motivation, and exploratory measures of anhedonia and depression severity were assessed at baseline and after one week of placebo and each dose of L-DOPA. Responses to individual doses of L-DOPA varied across outcomes. For example, VS-vmPFC rs-FC was significantly increased by L-DOPA at 150 and 450 mg/day/week (p < 0.01), whereby approximately half of patients responded optimally to 150 mg/day L-DOPA and approximately half required higher doses for maximum effect. While effort-based motivation was only significantly increased by L-DOPA at 150 mg/day (p < 0.05), it correlated with VS-vmPFC rs-FC at this dose (r = 0.64, p = 0.024), and all L-DOPA doses met a clinically significant threshold of ≥ 10 % increase versus placebo. When comparing the maximum response at any L-DOPA dose to placebo, high effect sizes were observed for these primary outcomes and tb-FC during reward anticipation (d_z = 0.82-0.98, p < 0.01), as well as secondary and exploratory measures of anhedonia and depression severity (d_z = 0.48-0.97, p < 0.05). Sustained effects on reward circuitry, effort-based motivation, and anhedonia by repeated L-DOPA administration support the therapeutic potential of agents that increase dopamine in depressed patients with higher inflammation.

168

News (Medical) associated with Carbidopa

06 Feb 2025

·www.pharmaceutical-technology.com

Supernus wins FDA approval for Parkinson’s pump on fourth try

Onapgo is approved for adult Parkinson’s patients experiencing motor fluctuations. Credit: Inside Creative House via Getty Images. Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of Parkinson’s disease. Supernus’ regulatory path for Onapgo has been marked by multiple setbacks over nearly five years, with the Food and Drug Administration (FDA) rejecting three prior applications before securing approval. The company acquired Onapgo, previously known as SPN-830, from US WorldMeds in 2020. Soon after, Supernus submitted its first application for FDA review. However, in 2020, the agency issued a refusal-to-file (RTF) letter, determining that the submission was incomplete and not ready for formal review. Supernus resubmitted the application twice, receiving complete response letters (CRLs) both times. The first 2022 rejection required further analysis of the infusion device and drug product, while the most recent CRL, issued in April 2023, cited product quality concerns and deficiencies in the master file for the proprietary pump. The company resubmitted its fourth application in August, leading to the current approval. Onapgo will now be available for adult Parkinson’s disease patients experiencing motor fluctuations. The wearable pump is designed to provide a continuous subcutaneous infusion of Supernus’ apomorphine (Apokyn). The drug is intended for patients experiencing “off” periods, where medication wears off and symptoms return or worsen. The approval is based on a Phase III, 12-week study (NCT02006121) involving 107 patients. Onapgo led to a drop in daily “off” time and an increase in daily good “on” time, defined as periods without dyskinesia and the patient’s global impression of change (PGIC). Supernus plans to launch Onapgo in the second quarter of 2025, supported by a team of specialists, a nurse education programme, and access support services. The approval adds Onapgo to a growing list of infusion-based Parkinson’s treatments. AbbVie ’s Vyalev (foscarbidopa and foslevodopa), a continuous subcutaneous infusion therapy combining prodrugs of carbidopa and levodopa, was approved in October 2024 after three regulatory attempts. The FDA’s initial rejection of Vyalev did not involve efficacy or safety concerns but requested additional information on the pump device. The second rejection followed findings of issues at a third-party manufacturer. AbbVie set a precedent in 2015 with its Parkinson’s disease infusion pump therapy Produodopa (foslevodopa foscarbidopa), sparking innovation in drug delivery systems as companies looked for alternatives for conventional oral treatments.

Drug ApprovalPhase 3

04 Feb 2025

·www.fiercepharma.com

Supernus' 4th try proves the charm with long-awaited FDA approval for Parkinson's infusion pump Onapgo

Supernus Pharmaceuticals has been trying to push its Onapgo across the FDA finish line since 2020. Three strikes and you’re out? Not for Supernus Pharmaceuticals and its Parkinson’s disease infusion pump.On its fourth attempt to pass muster with the FDA, the company’s SPN-830, now branded as Onapgo, finally earned the agency’s stamp of approval to treat motor fluctuations in adults with advanced Parkinson’s.Onapgo is a wearable pump designed to provide a continuous subcutaneous infusion of Supernus’ apomorphine (Apokyn). The drug is meant to allow patients more control over their daily "off" time, or the instances when patients' medicine wears off and symptoms return or worsen. A continuous treatment like Onapgo can “help to make days with Parkinson’s more predictable,” Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance, explained in Supernus' press release on Tuesday.In a phase 3 study, the drug cut down on patients' daily "off" time after 12 weeks of treatment while also providing a significant increase in daily "good on" time, periods when medication works as intended and patients don't experience involuntary movements.Onapgo represents a “novel approach” for those with Parkinson’s motor fluctuations and showcases the company’s “continued commitment to developing novel alternatives to manage Parkinson’s disease and other neurological conditions,” CEO Jack Khattar said in the company's press release.Supernus is already gearing up for a launch and intends to make the drug available in the second quarter of this year. It’s been nearly a five-year journey to this point for Supernus after the company acquired the device and Apokyn from US WorldMeds in 2020. After quickly filing for approval, the FDA responded with a refuse-to-file notice, meaning that the agency didn’t have enough information to perform a thorough review.Then, in 2022, the FDA shut down the company’s second approval bid with a complete response letter requesting more information on the drug's labeling, manufacturing and other factors, Supernus disclosed at the time.Most recently, the agency again issued a complete response letter upon Supernus’ third approval try. In its rejection letter last year, the agency cited issues with product quality and the drug’s master file. While the fourth time proved the charm for Supernus, it took AbbVie and its continuous subcutaneous Parkinson’s pump three tries to finally cross the FDA finish line in October. That treatment, Vyalev, is made up of prodrugs of standard-of-care medicines carbidopa and levodopa. Supernus’ Apokyn contributed $19.9 million to the company’s total sales over the third quarter of 2024. In 2023, the drug pulled in $75.1 million in full-year sales.

Phase 3Drug ApprovalClinical Result

04 Dec 2024

·www.prnewswire.com

Mitsubishi Tanabe Pharma America to Present Data on Investigational ND0612 at the 2024 Annual Meeting of the Parkinson Study Group

JERSEY CITY, N.J., Dec. 4, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of two abstracts on investigational ND0612 in Parkinson's disease (PD) at the 2024 Annual Meeting of the Parkinson Study Group (PSG), being held December 5-8 in Nashville, Tenn. ND0612 is being evaluated as a 24-hour, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD). "We look forward to attending the PSG meeting where we will discuss our latest findings on investigational ND0612 with other experts from the scientific community," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "This ongoing research is driven by our passion to support the Parkinson's disease community and continue investigating areas of significant unmet needs for patients." MTPA's posters will be presented in Grand Hall A, B & C on December 5, 5:00 p.m.-7:00 p.m. CST: Presentation Details: Presentations will discuss outcomes from the open-label, Phase 2b BeyoND study (NCT02726386), which evaluated the safety and efficacy of investigational ND0612 over three years in people with PD experiencing motor fluctuations, as well as a characterization of infusion site reactions (ISRs) reported from treatment with ND0612 in clinical studies. Continuous Subcutaneous Levodopa/Carbidopa Infusion with ND0612 for Parkinson's Disease: Three-Year Data from the Open-Label BeyoND Study (Jonathan Pereira, M.D.; MTPA) Characterization of Infusion Site Reactions (ISRs) with 24-Hour Subcutaneous Infusion of ND0612: Findings from an Integrated Safety Database (Jonathan Pereira, M.D.; MTPA) 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), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. 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 by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is 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 2

100 Deals associated with Carbidopa

External Link

KEGG	Wiki	ATC	Drug Bank
D00558	Carbidopa	N04BA03	DB00190

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Nausea	United States	Aton Pharma, Inc.	25 Apr 1977
Parkinson Disease	United States	Aton Pharma, Inc.	25 Apr 1977
Parkinson Disease, Postencephalitic	United States	Aton Pharma, Inc.	25 Apr 1977
Parkinson Disease, Secondary	United States	Aton Pharma, Inc.	25 Apr 1977
Vomiting	United States	Aton Pharma, Inc.	25 Apr 1977

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00983814 (ADD201, CTgov)	Phase 2	Attention Deficit Disorder With Hyperactivity	20	Carbidopa+Droxidopa (Droxidopa+Carbidopa: Double-Blind)	xlaanbvgdy(jbpgfrrvkm) = sinpmoezma jaanfzofob (jfkcnsxxlh, fmbxosodzx - iripkpevlo) View more	-	18 Apr 2024
				placebo+carbidopa+droxidopa (Placebo: Double-Blind)	xlaanbvgdy(jbpgfrrvkm) = kkqdmgntof jaanfzofob (jfkcnsxxlh, uagdlqqzgf - zidbwjipsa) View more
NCT02553265 (CarbiFD, CTgov)	Phase 2	Pure Autonomic Failure \| Dysautonomia, Familial	22	Placebo (Placebo)	xamopnndjm(bemqxbklfj) = stjlcxdnfs ufadxlkzdk (ugatgcmicg, okzfnyrtzi - erwqvggucy) View more	-	09 Feb 2022
				Carbidopa Low-Dose (Low-Dose Carbidopa)	xamopnndjm(bemqxbklfj) = yiwsbqdjfi ufadxlkzdk (ugatgcmicg, mnmicevxbr - pnhtzqhhfo) View more
NCT00685919 (CTgov)	Phase 2/3	Postural Orthostatic Tachycardia Syndrome	32	Placebo (Healthy Participants Who Received Placebo as Treatment A or Treatment B)	afovurpllu(ythwwcmwag) = qdyvmepkvt jxcqoljdco (dmzkfrxhan, caieklmaxy - xawqlzveql) View more	-	20 Sep 2021
				Carbidopa (Healthy Participants Who Received Carbidopa as Treatment A or Treatment B)	afovurpllu(ythwwcmwag) = pdxndagule jxcqoljdco (dmzkfrxhan, wlcllfqarr - lheqalffdp) View more
EANM2020	Not Applicable	Brain Cancer 18 F-FDOPA	-	Carbidopa premedication	yqviqegfux(ntjxpqniba) = nwlotnhpxu okrsdistyl (rwywjfrhwu ) View more	-	18 Sep 2020
				Carbidopa (No premedication)	yqviqegfux(ntjxpqniba) = oajrxrlayb okrsdistyl (rwywjfrhwu ) View more
MDS2020	Not Applicable	Parkinson Disease	255	Carbidopa (10 mg)	(pmfkwyzarb) = ktamcjoejj tystciafax (gjdojjqpgo )	Positive	12 Sep 2020
				Benserazide (25 mg)	(pmfkwyzarb) = vaxwkogtbw tystciafax (gjdojjqpgo )
NCT03115827 (CTgov)	Phase 4	Parkinson Disease	15	Carbidopa+Droxidopa	eewzegmclc(aiogowpjir) = fmpqvmfujc hxpgbazyfh (edkhlbvzvp, yopluashmr - toiincchyg) View more	-	27 Jan 2020
MDS2016	Not Applicable	-	-	Levodopa + Carbidopa	ffoueptkuk(stbjxtfyrw) = kywinmdivh snjypglprh (wfgyejplpi ) View more	-	19 Jun 2016
				Saline	ffoueptkuk(stbjxtfyrw) = qdihdflefl snjypglprh (wfgyejplpi ) View more
NCT01568073 (CTgov)	Phase 3	Parkinson Disease	600	Placebo+Carbidopa+Benserazide+Levodopa (Placebo)	vwbfiumzns(alpghzqsfv) = ewtpeawjyh yysikdonui (ggchcggytx, qufdylycqk - dritzwcvdp) View more	-	08 Jan 2015
				Carbidopa+Benserazide+Entacapone+Levodopa (Entacapone)	vwbfiumzns(alpghzqsfv) = dnzcgoguke yysikdonui (ggchcggytx, tjfhhybven - razwhasllf) View more

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