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

Last Updated: October 31, 2024

CLINICAL TRIALS PROFILE FOR SINEMET CR


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for SINEMET CR

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 NCT00363727 ↗ Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's Completed GlaxoSmithKline Phase 3 2003-12-01 This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for SINEMET CR

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.
NCT00006337 ↗ KW-6002 to Treat Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2000-10-01 This study will evaluate the effects of an experimental drug called KW-6002 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. This drug blocks the action of the neurotransmitter adenosine, thought to be involved in producing Parkinson's symptoms. Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 80 years of age may be eligible for this 7-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 enrolled in the study will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. For the first 1 to 3 days, patients will be admitted to the NIH Clinical center to undergo a levodopa "dose-finding" procedure. For this study, patients will stop taking Sinemet and instead will have levodopa infused through a vein for up to 8 hours/day. During the infusions, the drug dose will be increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than what is needed to relieve symptoms, and 2) one that relieves symptoms but may produce dyskinesias. This procedure will be repeated at the end of weeks 2, 4 and 6 of the study. When the patient's optimal dose is determined treatment will begin. Patients will take tablets or capsules containing KW-6002 or placebo (a look-alike pill with no active ingredient) once a day for 2 weeks, in addition to their regular Sinemet. All participants will receive placebo at least 2 weeks during the study; some patients will receive only placebo throughout the entire 7 weeks. At the end of weeks 1, 3 and 5, patients will be evaluated with a brief physical examination, routine blood and urine tests, and assessment of any adverse effects. Throughout the study, parkinsonian symptoms and dyskinesias will be evaluated and blood samples will be drawn periodically to measure drug levels.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SINEMET CR

Condition Name

Condition Name for SINEMET CR
Intervention Trials
Parkinson's Disease 31
Parkinson Disease 17
Depression 5
Dyskinesias 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for SINEMET CR
Intervention Trials
Parkinson Disease 53
Dyskinesias 6
Depressive Disorder 4
Stroke 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for SINEMET CR

Trials by Country

Trials by Country for SINEMET CR
Location Trials
United States 154
Canada 8
Italy 6
Finland 6
Spain 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for SINEMET CR
Location Trials
Maryland 12
California 11
Georgia 10
Texas 10
Illinois 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for SINEMET CR

Clinical Trial Phase

Clinical Trial Phase for SINEMET CR
Clinical Trial Phase Trials
Phase 4 12
Phase 3 5
Phase 2/Phase 3 3
[disabled in preview] 29
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for SINEMET CR
Clinical Trial Phase Trials
Completed 61
Recruiting 10
Terminated 4
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for SINEMET CR

Sponsor Name

Sponsor Name for SINEMET CR
Sponsor Trials
National Institute of Neurological Disorders and Stroke (NINDS) 13
Bial - Portela C S.A. 7
Orion Corporation, Orion Pharma 7
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for SINEMET CR
Sponsor Trials
Other 63
Industry 45
NIH 28
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.