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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR ROPINIROLE HYDROCHLORIDE

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Clinical Trials for Ropinirole Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00036218 Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease. Completed Pfizer Phase 3 The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.
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.
NCT00140712 Ropinirole Tablets In Young Patients With Restless Legs Syndrome Completed GlaxoSmithKline Phase 1 This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ropinirole Hydrochloride

Condition Name

Condition Name for Ropinirole Hydrochloride
Intervention Trials
Parkinson Disease 21
Restless Legs Syndrome 20
Parkinson's Disease 14
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Condition MeSH

Condition MeSH for Ropinirole Hydrochloride
Intervention Trials
Parkinson Disease 34
Restless Legs Syndrome 22
Psychomotor Agitation 19
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Clinical Trial Locations for Ropinirole Hydrochloride

Trials by Country

Trials by Country for Ropinirole Hydrochloride
Location Trials
United States 310
Germany 41
Italy 19
United Kingdom 18
Canada 12
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Trials by US State

Trials by US State for Ropinirole Hydrochloride
Location Trials
California 17
Florida 16
Texas 15
New York 15
Georgia 15
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Clinical Trial Progress for Ropinirole Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Ropinirole Hydrochloride
Clinical Trial Phase Trials
Phase 4 16
Phase 3 27
Phase 2 10
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Clinical Trial Status

Clinical Trial Status for Ropinirole Hydrochloride
Clinical Trial Phase Trials
Completed 60
Unknown status 4
Recruiting 3
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Clinical Trial Sponsors for Ropinirole Hydrochloride

Sponsor Name

Sponsor Name for Ropinirole Hydrochloride
Sponsor Trials
GlaxoSmithKline 38
UCB Pharma 4
Otsuka Pharmaceutical Co., Ltd. 3
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Sponsor Type

Sponsor Type for Ropinirole Hydrochloride
Sponsor Trials
Industry 63
Other 24
NIH 2
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