You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 3, 2025

CLINICAL TRIALS PROFILE FOR CARBIDOPA; LEVODOPA


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Carbidopa; Levodopa

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
New Combination NCT01766258 ↗ Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations Completed Orion Corporation, Orion Pharma Phase 2 2011-05-01 The primary objective of the study is to assess the efficacy, carbidopa dose response and safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.
New Formulation NCT00640159 ↗ Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease Completed Baylor College of Medicine Phase 4 2007-01-01 Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

All Clinical Trials for Carbidopa; Levodopa

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00125567 ↗ Stalevo in Early Wearing-Off Patients Completed Orion Corporation, Orion Pharma Phase 4 2005-08-01 The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.
NCT00129181 ↗ Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease Completed GE Healthcare N/A 2005-01-01 This study investigates whether there is a change in 123iodine-2ß- carbomethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) uptake after short-term treatment with levodopa compared to either dopamine agonist or placebo.
NCT00129181 ↗ Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease Completed Pfizer N/A 2005-01-01 This study investigates whether there is a change in 123iodine-2ß- carbomethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) uptake after short-term treatment with levodopa compared to either dopamine agonist or placebo.
NCT00129181 ↗ Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease Completed Institute for Neurodegenerative Disorders N/A 2005-01-01 This study investigates whether there is a change in 123iodine-2ß- carbomethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) uptake after short-term treatment with levodopa compared to either dopamine agonist or placebo.
NCT00099268 ↗ Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy Completed Orion Corporation, Orion Pharma Phase 3 2004-09-01 The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
NCT00099268 ↗ Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy Completed Novartis Pharmaceuticals Phase 3 2004-09-01 The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
NCT00086294 ↗ ACP-103 to Treat Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2004-06-25 This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are affected in patients with Parkinson's disease. Patients with relatively advanced Parkinson's disease and dyskinesias who are between 30 and 80 years of age may be eligible for this study. Candidates are screened with a complete medical history and physical examination, neurological evaluation, blood and urine tests, and electrocardiogram (ECG). A brain magnetic resonance imaging (MRI) scan, CT scan, and chest x-ray may be done if medically indicated. Patients enrolled in the study will, if possible, stop taking all antiparkinsonian medications for one month (2 months for Selegiline) before the study begins and throughout its duration. Exceptions are Sinemet (levodopa/carbidopa), Mirapex (pramipexole) and Requip (ropinirole). Levodopa Dose Finding After the screening evaluations, patients are admitted to the NIH Clinical Center for 2 to 3 days to undergo a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusion, the drug dose is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Side effects are monitored closely during the infusions, and parkinsonian symptoms are evaluated frequently during and after the infusions. The infusions usually begin early in the morning and continue until evening. Once the infusion is finished, patients resume taking their regular oral Sinemet dose. The infusions are repeated once a week during 1-day inpatient evaluations. Treatment Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill with no active ingredient) once a week for 10 weeks or vice versa (placebo followed by ACP-103). Patients are admitted to the Clinical Center for each dose. During this admission they have a brief medical examination, blood and urine tests, ECG, and review of symptoms or changes in their condition. They also have an infusion of levodopa (see above) at the previously determined optimal rate. Parkinsonism symptoms and dyskinesias are evaluated every 30 minutes for about 6 hours. At the end of the infusions and ratings, patients are discharged home with their regular Parkinson's medications until the following visit. Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for a follow-up safety check. At that time, the investigator may ask the patient to return to the clinic for closer evaluation.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for Carbidopa; Levodopa

Condition Name

7034990010203040506070Parkinson's DiseaseParkinson DiseaseAdvanced Parkinson's DiseaseParkinson's Disease (PD)[disabled in preview]
Condition Name for Carbidopa; Levodopa
Intervention Trials
Parkinson's Disease 70
Parkinson Disease 34
Advanced Parkinson's Disease 9
Parkinson's Disease (PD) 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

1340020406080100120140Parkinson DiseaseDepressionDyskinesiasDepressive Disorder[disabled in preview]
Condition MeSH for Carbidopa; Levodopa
Intervention Trials
Parkinson Disease 134
Depression 7
Dyskinesias 7
Depressive Disorder 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Carbidopa; Levodopa

Trials by Country

+
Trials by Country for Carbidopa; Levodopa
Location Trials
United States 550
Italy 41
Canada 40
Germany 39
Spain 33
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

+
Trials by US State for Carbidopa; Levodopa
Location Trials
California 38
Florida 34
New York 29
Illinois 29
Texas 28
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Carbidopa; Levodopa

Clinical Trial Phase

15.5%19.3%63.5%0020406080100120Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Carbidopa; Levodopa
Clinical Trial Phase Trials
Phase 4 28
Phase 3 35
Phase 2/Phase 3 3
[disabled in preview] 115
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

72.2%8.3%6.7%12.8%020406080100120140CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for Carbidopa; Levodopa
Clinical Trial Phase Trials
Completed 130
Recruiting 15
Not yet recruiting 12
[disabled in preview] 23
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Carbidopa; Levodopa

Sponsor Name

trials0510152025303540Bial - Portela C S.A.IMPAX Laboratories, Inc.Impax Laboratories, LLC[disabled in preview]
Sponsor Name for Carbidopa; Levodopa
Sponsor Trials
Bial - Portela C S.A. 13
IMPAX Laboratories, Inc. 12
Impax Laboratories, LLC 12
[disabled in preview] 38
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

53.0%39.0%6.3%0020406080100120140160IndustryOtherNIH[disabled in preview]
Sponsor Type for Carbidopa; Levodopa
Sponsor Trials
Industry 159
Other 117
NIH 19
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Carbidopa and Levodopa: Clinical Trials, Market Analysis, and Projections

Introduction to Carbidopa and Levodopa

Carbidopa and levodopa are a cornerstone in the treatment of Parkinson's disease (PD), a progressive neurological disorder characterized by the loss of dopamine-producing neurons in the brain. Levodopa, also known as L-DOPA, is a precursor to dopamine that crosses the blood-brain barrier and is converted into dopamine, thereby alleviating motor symptoms such as tremors, stiffness, and bradykinesia associated with PD[3].

Clinical Trials: IPX203 vs Immediate-Release Carbidopa-Levodopa

Recent clinical trials have focused on improving the delivery and efficacy of carbidopa-levodopa. One notable study is the RISE-PD trial, which compared IPX203, an oral, extended-release formulation of carbidopa-levodopa, with immediate-release carbidopa-levodopa.

Study Design and Participants

The RISE-PD trial was a 20-week, randomized, double-blind, double-dummy, active-controlled phase 3 clinical trial conducted at 105 academic and clinical centers in the US and Europe. The study involved 630 patients with PD who were experiencing motor fluctuations and were taking a total daily dose of 400 mg or more of levodopa[4].

Interventions and Outcomes

Patients underwent an open-label immediate-release carbidopa-levodopa dose adjustment for 3 weeks, followed by a conversion to IPX203 for 4 weeks. They were then randomized to receive either IPX203 or immediate-release carbidopa-levodopa for 13 weeks. The primary endpoint was the mean change in daily "good on-time" (time without troublesome dyskinesia) from baseline to the end of the double-blind treatment period.

Results

The study demonstrated that IPX203 provided statistically significant improvement in daily good on-time compared to immediate-release carbidopa-levodopa. Patients on IPX203 experienced an increase of 0.53 hours in good on-time per day, despite being dosed a mean of 3 times per day compared to 5 times per day for immediate-release carbidopa-levodopa. Good on-time per dose increased by 1.55 hours with IPX203[1][4].

Market Analysis

Market Size and Growth

The global levodopa market, which includes carbidopa-levodopa combination drugs, was valued at $1.7 billion in 2022 and is projected to reach $2.9 billion by 2032, growing at a CAGR of 6.1% from 2023 to 2032. This growth is driven by the increasing prevalence of Parkinson's disease, longer life expectancy, and changing lifestyle patterns[3].

Dominance of Carbidopa-Levodopa Segment

The carbidopa-levodopa drug class segment dominates the Parkinson's disease treatment market. In 2021, this segment accounted for more than 25% of the market revenue due to its high prescription rate and long-term effectiveness. According to U.S. Drug Use Statistics, there were 527,530 prescriptions for carbidopa-levodopa for 183,690 Parkinson’s patients in 2020[5].

Key Players and Market Drivers

Key players in the Parkinson's disease treatment market include Cerevel Therapeutics, Novartis AG, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., GlaxoSmithKline plc., AbbVie, Inc., H. Lundbeck A/S, and Amneal Pharmaceuticals LLC. The market growth is driven by a strong product pipeline, the approval of disease-modifying therapies, and the rising disease burden of Parkinson’s in developed countries[5].

Market Projections

Future Trends and Opportunities

The levodopa market is expected to continue growing due to several key trends:

  • Advancements in Drug Delivery Systems: Extended-release formulations like IPX203 are designed to provide more sustained benefits throughout the day with fewer doses, improving patient compliance and outcomes[1][4].
  • Personalized Medicine: There is an increasing focus on personalized treatment approaches, which could further enhance the efficacy of carbidopa-levodopa therapies[3].
  • Disease-Modifying Treatments: Ongoing research into disease-modifying treatments for Parkinson’s disease is expected to shape treatment efficacy and patient outcomes in the future[3].

Global Market Forecast

The global Parkinson’s disease therapeutics market, including the levodopa segment, is anticipated to grow significantly. The levodopa combination drugs segment is poised to maintain its leading share of the global market during the forecast period from 2023 to 2032[2].

Challenges and Considerations

Side Effects and Complications

Long-term use of levodopa can lead to complications such as dyskinesias. Combining levodopa with carbidopa helps reduce these side effects by inhibiting the conversion of levodopa to dopamine outside the brain, thereby enhancing its effectiveness and reducing adverse reactions[3].

Patient Compliance

The complexity of dosing schedules, particularly with immediate-release formulations, can affect patient compliance. Extended-release formulations like IPX203 aim to simplify dosing regimens, which can improve adherence and overall treatment outcomes[1][4].

Key Takeaways

  • Clinical Efficacy: IPX203, an extended-release formulation of carbidopa-levodopa, has shown statistically significant improvement in daily good on-time compared to immediate-release carbidopa-levodopa.
  • Market Dominance: The carbidopa-levodopa segment dominates the Parkinson’s disease treatment market due to its high prescription rate and long-term effectiveness.
  • Market Growth: The global levodopa market is projected to grow at a CAGR of 6.1% from 2023 to 2032, driven by the increasing prevalence of Parkinson’s disease and advancements in drug delivery systems.
  • Future Trends: Personalized medicine and disease-modifying treatments are expected to shape the future of Parkinson’s disease management.

FAQs

What is the primary benefit of IPX203 over immediate-release carbidopa-levodopa?

IPX203 provides more hours of good on-time per day with fewer doses, improving patient compliance and outcomes.

Why is the levodopa market growing?

The levodopa market is growing due to the increasing prevalence of Parkinson’s disease, longer life expectancy, and changing lifestyle patterns.

What are the common side effects of long-term levodopa use?

Long-term use of levodopa can lead to complications such as dyskinesias, which can be mitigated by combining levodopa with carbidopa.

Which segment dominates the Parkinson’s disease treatment market?

The carbidopa-levodopa drug class segment dominates the Parkinson’s disease treatment market due to its high prescription rate and long-term effectiveness.

What are the key trends influencing the levodopa market?

Advancements in drug delivery systems, an increase in focus on personalized medicine, and continued research into disease-modifying treatments are key trends influencing the levodopa market.

Sources

  1. JAMA Neurology: "IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Patients With Parkinson Disease: A Randomized Clinical Trial"[1].
  2. BioSpace: "Parkinson's Disease Therapeutics Market: The Levodopa Combination Drugs Segment Is Poised to Account for the Leading Share of the Global Market During 2017 to 2025"[2].
  3. Allied Market Research: "Levodopa Market Size, Growth Analysis | Forecast - 2032"[3].
  4. PubMed: "IPX203 vs Immediate-Release Carbidopa-Levodopa for Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial"[4].
  5. Grand View Research: "Parkinson's Disease Treatment Market Size Report, 2030"[5].

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.