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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR CARBIDOPA; LEVODOPA

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Clinical Trials for Carbidopa; Levodopa

Trial ID Title Status Sponsor Phase Summary
NCT00086294 ACP-103 to Treat Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Carbidopa; Levodopa

Condition Name

Condition Name for Carbidopa; Levodopa
Intervention Trials
Parkinson's Disease 67
Parkinson Disease 22
Advanced Parkinson's Disease 9
Parkinson's Disease (PD) 5
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Condition MeSH

Condition MeSH for Carbidopa; Levodopa
Intervention Trials
Parkinson Disease 114
Dyskinesias 6
Cocaine-Related Disorders 5
Macular Degeneration 4
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Clinical Trial Locations for Carbidopa; Levodopa

Trials by Country

Trials by Country for Carbidopa; Levodopa
Location Trials
United States 361
Canada 31
Germany 24
Italy 23
Poland 20
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Trials by US State

Trials by US State for Carbidopa; Levodopa
Location Trials
California 28
Florida 25
Michigan 23
Texas 20
Illinois 20
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Clinical Trial Progress for Carbidopa; Levodopa

Clinical Trial Phase

Clinical Trial Phase for Carbidopa; Levodopa
Clinical Trial Phase Trials
Phase 4 22
Phase 3 30
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Carbidopa; Levodopa
Clinical Trial Phase Trials
Completed 101
Recruiting 20
Active, not recruiting 7
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Clinical Trial Sponsors for Carbidopa; Levodopa

Sponsor Name

Sponsor Name for Carbidopa; Levodopa
Sponsor Trials
Bial - Portela C S.A. 13
IMPAX Laboratories, Inc. 11
Orion Corporation, Orion Pharma 11
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Sponsor Type

Sponsor Type for Carbidopa; Levodopa
Sponsor Trials
Industry 115
Other 76
NIH 13
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