CLINICAL TRIALS PROFILE FOR ROPINIROLE HYDROCHLORIDE
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505(b)(2) Clinical Trials for ROPINIROLE HYDROCHLORIDE
| 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. |
| New Formulation | NCT03250117 ↗ | Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole | Terminated | Titan Pharmaceuticals | Phase 1/Phase 2 | 2017-10-10 | Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant technology where the implant is inserted under the skin. This study will measure how much ropinirole is released in the blood during 3 months of treatment, and evaluate the side effects of this new formulation. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for ROPINIROLE HYDROCHLORIDE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00036218 ↗ | Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease. | Completed | Pfizer | Phase 3 | 2001-12-01 | 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 | 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. |
| NCT00140712 ↗ | Ropinirole Tablets In Young Patients With Restless Legs Syndrome | Completed | GlaxoSmithKline | Phase 1 | 2005-06-10 | 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. |
| NCT00144300 ↗ | Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients | Completed | Boehringer Ingelheim | Phase 4 | 2005-01-01 | To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years. |
| NCT00197080 ↗ | Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome | Completed | GlaxoSmithKline | Phase 3 | 2005-06-01 | The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS). |
| NCT00200941 ↗ | Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome | Completed | Ortho-McNeil Pharmaceutical | Phase 4 | 2001-08-01 | This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome. |
| NCT00200941 ↗ | Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome | Completed | Neurocare | Phase 4 | 2001-08-01 | This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for ROPINIROLE HYDROCHLORIDE
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