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Last Updated: May 18, 2025

CLINICAL TRIALS PROFILE FOR CARBIDOPA


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505(b)(2) Clinical Trials for Carbidopa

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
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.
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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Carbidopa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00028106 ↗ 131MIBG to Treat Malignant Pheochromocytoma Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 2001-12-05 This study will evaluate the effectiveness of 131MIBG in treating malignant pheochromocytoma and whether sensitization medications improve the response to treatment. Pheochromocytoma is a rare type of tumor that usually occurs in the adrenal glands. The tumor cells release chemicals like adrenaline that can cause large increases in blood pressure and pulse rate, with serious health consequences. Tumor in the adrenal glands usually can be removed surgically, but if the pheochromocytoma is malignant-i.e., has spread to many sites in the body-or is located in places where surgery is difficult or impossible, no satisfactory treatment is available. 131MIBG is a combination of an adrenaline-like chemical and a radioactive form of iodine. The 131MIBG attaches to the tumor cells and the high concentration of radioactive iodine kills them. Previous studies using 131MIBG to treat pheochromocytoma had a 36% response rate in terms of complete or partial improvement. This study will examine whether adding other sensitization medications to the 131MIBG treatment regimen will enhance its effectiveness in reducing the size and number of tumors. Patients 18 years of age and older with malignant or inoperable pheochromocytoma may be eligible for this 18-month study. Candidates will be screened with various tests and procedures, which may include a medical history, physical examination, blood and urine tests, lung function studies, electrocardiogram, echocardiogram, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and bone scans and other scans using radioactive MIBG and octreotide. Participants will be randomly assigned to one of two treatment groups: 1) 131MIBG plus sensitization medications, or 2) 131MIBG alone. All patients will be hospitalized 3 to 5 days for each 131MIBG treatment. The drug will be infused through a vein (intravenously, or I.V.) over 10 to 30 minutes. Patients will receive up to 3 treatments, separated by at least 3 months. All patients will also take potassium to protect the thyroid gland from radioactive iodine generated by the 131MIBG. The potassium is taken twice a day for 30 days, beginning the day before the 131MIBG treatment. Patients in the sensitization group will receive the following additional drugs for sensitization: methylprednisolone, intravenously a few minutes before 131MIBG treatment; Roaccutan, by mouth (capsules) twice a day for 6 weeks before treatment; Demser, by mouth 3 times a week for 1 week before treatment, and Carbidopa, by mouth every 6 hours for 4 days before treatment. After each treatment, patients will have a clinical evaluation and periodic blood tests to check for adverse side effects of radiotherapy. Follow-up visits at NIH will be scheduled at 12 and 18 months after the first 131MIBG treatment for clinical, laboratory and imaging tests. Patients who had tumors in the lungs before treatment will have lung function tests 1, 3, and 6 months after each treatment. CT, MRI 131MIBG, and PET scanning will be done 1 week before each treatment. Patients who have tumors that have grown by more than 25% and none that have shrunk by more than 50% or who have developed one or more new tumors while on 131MIBG treatment will be taken off the study.
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.
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.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Carbidopa

Condition Name

Condition Name for Carbidopa
Intervention Trials
Parkinson's Disease 72
Parkinson Disease 38
Advanced Parkinson's Disease 9
Parkinson's Disease (PD) 9
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Condition MeSH

Condition MeSH for Carbidopa
Intervention Trials
Parkinson Disease 141
Dyskinesias 7
Depression 5
Cocaine-Related Disorders 5
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Clinical Trial Locations for Carbidopa

Trials by Country

Trials by Country for Carbidopa
Location Trials
United States 580
Germany 41
Italy 41
Canada 40
Spain 33
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Trials by US State

Trials by US State for Carbidopa
Location Trials
California 40
Florida 38
Texas 31
New York 31
Michigan 31
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Clinical Trial Progress for Carbidopa

Clinical Trial Phase

Clinical Trial Phase for Carbidopa
Clinical Trial Phase Trials
Phase 4 27
Phase 3 38
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Carbidopa
Clinical Trial Phase Trials
Completed 146
Recruiting 18
Not yet recruiting 13
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Clinical Trial Sponsors for Carbidopa

Sponsor Name

Sponsor Name for Carbidopa
Sponsor Trials
Bial - Portela C S.A. 15
Orion Corporation, Orion Pharma 14
Impax Laboratories, LLC 13
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Sponsor Type

Sponsor Type for Carbidopa
Sponsor Trials
Industry 174
Other 138
NIH 18
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Transforming Parkinson’s Treatment: Updates on Carbidopa Clinical Trials, Market Analysis, and Projections

Introduction to Carbidopa and Levodopa in Parkinson’s Disease

Carbidopa and levodopa are cornerstone treatments for Parkinson’s disease (PD), a neurodegenerative disorder characterized by motor symptoms such as tremor, slowness, and stiffness. These medications work by temporarily replacing lost dopamine in the brain, with carbidopa enhancing the uptake of levodopa.

Recent Clinical Trials and FDA Approvals

Vyalev: Infusion-Based Treatment

In a significant advancement, the FDA has approved AbbVie’s Vyalev, an infusion-based treatment for advanced Parkinson’s disease. This treatment involves a continuous under-the-skin infusion of levodopa/carbidopa, similar to insulin therapy for diabetes. A Phase 3 study demonstrated that Vyalev increased “on” time by approximately three hours compared to immediate-release oral carbidopa/levodopa, reducing motor fluctuations and improving symptom control[1].

Crexont: Long-Acting Oral Formulation

Amneal Pharmaceuticals has also received FDA approval for Crexont, a new long-acting oral formulation of levodopa/carbidopa. This medication combines immediate- and extended-release levodopa plus carbidopa in one pill, aiming to provide longer symptom control with fewer doses. Clinical trials showed improvements in “on” time, with each dose of Crexont lasting about 1.5 hours longer than immediate-release levodopa/carbidopa[4].

IPX-203: Extended-Release Formulation

Amneal is also testing IPX-203, an extended-release formulation of carbidopa and levodopa, designed to reduce symptom fluctuations. This formulation is expected to smooth out the troughs and spikes in plasma levels associated with traditional CD/LD treatments, potentially reducing side effects like dyskinesia. Phase III safety results were anticipated by the end of the second quarter of 2022[3].

Market Analysis and Projections

Current Market Size and Growth

The global Parkinson’s disease treatment market, dominated by the carbidopa-levodopa drug class, was valued at USD 4.28 billion in 2021 and is expected to reach USD 4.61 billion in 2022. This market is projected to grow at a compound annual growth rate (CAGR) of 12.1% from 2022 to 2030, reaching USD 11.98 billion by 2030[2].

Market Segments and Distribution Channels

The market is segmented by drug class, distribution channel, and region. The carbidopa-levodopa segment holds a significant revenue share, while hospital pharmacies, retail pharmacies, and online pharmacies are key distribution channels. North America, Europe, and the Asia Pacific are major regional markets[2].

Market Drivers and Opportunities

Several factors drive the growth of the carbidopa and levodopa market. These include the increasing aging population worldwide, the use of telemedicine and online pharmacies to enhance accessibility, and expanding access to neurological treatments in developing markets. However, market growth is also influenced by challenges such as fiscal strain from R&D investments, insurance coverage issues, and inadequate healthcare infrastructure in emerging markets[5].

Side Effects and Safety Considerations

Common Side Effects of New Formulations

While the new formulations offer significant benefits, they also come with side effects. For Vyalev, common side effects include problems with the infusion site (such as redness and swelling), hallucinations, and dyskinesia. For Crexont and IPX-203, the focus is on reducing side effects associated with traditional CD/LD treatments, such as dyskinesia and motor fluctuations[1][3][4].

Regulatory and Insurance Coverage

FDA Approval and Regulatory Processes

The FDA approval of new treatments like Vyalev and Crexont is a crucial step, but additional regulatory and insurance coverage processes must be completed before these treatments become widely available. AbbVie expects Medicare coverage for Vyalev by the second half of 2025, highlighting the ongoing efforts to ensure accessibility and affordability[1].

Expert Insights and Future Directions

Quotes from Industry Experts

"New extended-release versions of CD/LD could smooth out these drops [in plasma levels], reducing side effects like dyskinesia," notes Dr. Jeffrey Kordower, emphasizing the potential benefits of formulations like IPX-203[3].

Ongoing Research and Development

The Michael J. Fox Foundation is monitoring 151 priority treatments in clinical testing for Parkinson’s disease, indicating a robust pipeline of potential therapies. This includes several additional therapies expected to go through the regulatory process in 2024, further expanding treatment options for patients[4].

Illustrative Statistics

  • Market Growth: The global Parkinson’s disease treatment market is expected to grow from USD 4.61 billion in 2022 to USD 11.98 billion by 2030, at a CAGR of 12.1%[2].
  • Revenue Share: The carbidopa-levodopa drug class segment dominated the market with a revenue share of more than 25% in 2021[2].
  • Peak Sales: IPX-203 is forecasted to reach peak sales of $127 million in 2028, according to GlobalData's consensus forecast[3].

Key Takeaways

  • Innovative Delivery Methods: New treatments like Vyalev offer continuous infusion, significantly improving “on” time for patients with advanced Parkinson’s disease.
  • Extended-Release Formulations: Crexont and IPX-203 aim to reduce symptom fluctuations and side effects associated with traditional CD/LD treatments.
  • Market Growth: The Parkinson’s disease treatment market is expected to grow substantially, driven by an aging population and expanding access to treatments.
  • Regulatory and Insurance Coverage: Ongoing processes are necessary to ensure new treatments are widely available and covered by insurance.

FAQs

What is the significance of the FDA approval of Vyalev for Parkinson’s disease?

The FDA approval of Vyalev marks a significant advancement in Parkinson’s treatment by providing a continuous infusion of levodopa/carbidopa, which increases “on” time and reduces motor fluctuations.

How does Crexont differ from traditional levodopa/carbidopa treatments?

Crexont combines immediate- and extended-release levodopa plus carbidopa in one pill, providing longer symptom control with fewer doses compared to traditional immediate-release formulations.

What are the potential benefits of IPX-203?

IPX-203, an extended-release formulation of carbidopa and levodopa, is designed to smooth out plasma level fluctuations, potentially reducing side effects like dyskinesia.

What are the key drivers of the Parkinson’s disease treatment market growth?

The market is driven by the increasing aging population, use of telemedicine and online pharmacies, and expanding access to neurological treatments in developing markets.

When can patients expect Medicare coverage for Vyalev?

AbbVie expects Medicare coverage for Vyalev by the second half of 2025, following the completion of additional regulatory processes.

Sources

  1. FDA Approves New Infusion-based Treatment for Parkinson's - Michael J. Fox Foundation
  2. Parkinson's Disease Treatment Market Size Report, 2030 - Grand View Research
  3. Parkinson's disease: major drug trial results to watch in 2022 - Clinical Trials Arena
  4. FDA approves new levodopa/carbidopa formulation for use in Parkinson's - Michael J. Fox Foundation
  5. Carbidopa & Levodopa Tablets Market Size & Share 2025-2030 - 360iResearch
Last updated: 2025-01-07

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