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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00650104 |
The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: Ropinirole XL (formerly CR) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson''s Disease Who Completed the Previous Ropinirole CR Studies 167 or 164 |
Estimated Enrollment: | 83 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 101468/196 |
Study First Received: | March 27, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00650104 |
Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency |
Parkinson's disease open-label long term safety; REQUIP ropinirole IR |
ropinirole CR ropinirole XL safety efficacy |
Ropinirole Dopamine Ganglion Cysts Movement Disorders Parkinson Disease |
Basal Ganglia Diseases Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Antiparkinson Agents Dopamine Agents Dopamine Agonists Central Nervous System Agents Pharmacologic Actions |