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Last Updated: October 20, 2019

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CLINICAL TRIALS PROFILE FOR SINEMET

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Clinical Trials for Sinemet

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004576 Study of LY300164 for the Treatment of Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2000-02-01 This study will test the effectiveness of an experimental drug called LY300164 on improving Parkinson's disease symptoms, such as movement impairments and tremor, as well as involuntary movements produced by long-term treatment with levodopa. Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 75 years of age may be eligible for this 8-week study. Participants will have a complete medical history and physical examination, including blood tests and an electrocardiogram, and possibly brain magnetic resonance imaging (MRI), CT scan, and chest X-ray. Patients will stop taking all anti-parkinsonism medications except levodopa (Sinemet) and the experimental drug during the study. For the first 1 to 3 days, patients will be in the hospital for a levodopa "dose-finding" procedure. For this study, levodopa is infused through a vein for up to 8 hours, with symptoms monitored frequently to determine the doses that will produce two results: 1) the dose that is less than what is needed to relieve symptoms, and 2) the dose that relieves symptoms, but may produce dyskinesias. When these dose rates are determined, patients will begin treatment in one of two groups. One will take LY300164 3 times a day, along with levodopa, for 3 weeks. The second group will take placebo tablets (a look-alike tablet with no active ingredient) and levodopa on the same schedule as the LY300164 group. A brief medical examination and routine blood and urine tests will be done weekly. The drug dose will be increased every 3 to 4 days until significant side effects occur or the maximal dose is reached. Patients will be closely monitored for 4 hours after every increase. At the end of the 3 weeks, or when the maximal dose is reached, patients will be readmitted to the hospital for 2 to 3 days for a second levodopa dose-finding study, while continuing on LY300164 or placebo. After this test, patients will resume taking levodopa and the experimental drug or placebo as before for another 2 weeks. At the end of the 2-weeks, the entire procedure will be repeated in both groups, but the treatments will be switched-that is, the patients who were taking LY300164 will now take placebo, and the patients who took placebo will now take the drug. At the end of the second 3 weeks, the levodopa infusion procedure will be repeated once more. Throughout the study, parkinsonism symptoms and dyskinesias will be evaluated and blood samples will be drawn periodically to measure drug levels.
NCT00004733 Timing of Levodopa Treatment in Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 3 1998-01-01 The ELLDOPA study is a controlled clinical trial in patients with newly diagnosed PD to determine the optimal timing and dosing with levodopa (Sinemet or its generic equivalents).
NCT00006077 Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2000-08-01 This study will evaluate the effects of an experimental drug called NS2330 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. This drug prevents the neurotransmitter dopamine from entering nerve cells. Patients between 18 and 75 years old who have moderately advanced Parkinson's disease and motor problems resulting from levodopa therapy may be eligible for this 5-week study. Candidates will have a complete medical history and physical examination with a detailed neurological evaluation. If needed, some patients will undergo a magnetic resonance imaging (MRI) or computerized tomography (CT) scan of the brain and a chest X-ray. All patients will have blood and urine tests and an electrocardiogram (EKG) and will take a written test for evaluation of depression. Patients enrolled in the study will, if possible, stop taking all antiparkinson medications except levodopa (Sinemet) for one month before the study begins and through its duration. For the first 1 to 3 days, patients will undergo a levodopa "dose-finding" procedure. For this study, patients will stop taking their usual oral levodopa medicine and instead will have levodopa infused through a vein for up to 12 hours. During the infusions, the drug dose will be increased slowly until either 1) parkinsonism symptoms improve, 2) dyskinesias appear, 3) unacceptable side effects occur, or 4) the maximum study dose is reached. When the patient's optimal dose is determined, treatment will begin. Patients will take three pills containing NS2330 or placebo (a look-alike pill with no active ingredient) 3 days a week for up to 5 weeks, in addition to their regular levodopa medication. All participants will receive placebo at some point in the study; some patients will receive only placebo throughout the entire 5 weeks. On treatment days, patients will have a brief medical examination before receiving the drug and will then be monitored for side effects for about 6 to 8 hours after taking the drug. At the beginning of weeks 2 and 5, the levodopa infusions will be repeated at the previously determined optimum rate. Throughout the study, parkinsonism symptoms, dyskinesias and depression will be evaluated. Blood and urine samples will be collected each week for standard safety tests, and blood will also be drawn periodically to measure NS2330 levels.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sinemet

Condition Name

Condition Name for Sinemet
Intervention Trials
Parkinson's Disease 31
Parkinson Disease 15
Dyskinesias 5
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Condition MeSH

Condition MeSH for Sinemet
Intervention Trials
Parkinson Disease 51
Dyskinesias 6
Syndrome 3
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Clinical Trial Locations for Sinemet

Trials by Country

Trials by Country for Sinemet
Location Trials
United States 133
Canada 7
Italy 6
Finland 6
Spain 5
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Trials by US State

Trials by US State for Sinemet
Location Trials
Maryland 12
Michigan 9
California 9
Texas 9
Illinois 8
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Clinical Trial Progress for Sinemet

Clinical Trial Phase

Clinical Trial Phase for Sinemet
Clinical Trial Phase Trials
Phase 4 8
Phase 3 6
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Sinemet
Clinical Trial Phase Trials
Completed 46
Recruiting 16
Terminated 3
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Clinical Trial Sponsors for Sinemet

Sponsor Name

Sponsor Name for Sinemet
Sponsor Trials
National Institute of Neurological Disorders and Stroke (NINDS) 12
Bial - Portela C S.A. 7
Orion Corporation, Orion Pharma 7
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Sponsor Type

Sponsor Type for Sinemet
Sponsor Trials
Other 42
Industry 40
NIH 18
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