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Sponsors and Collaborators: |
University of California, Irvine GlaxoSmithKline |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00221390 |
The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke.
Condition | Intervention | Phase |
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Cerebrovascular Accident Hemiparesis |
Drug: Ropinirole (+ physical therapy) Drug: (vs.) Placebo + physical therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Placebo-Controlled, Double-Blind Pilot Trial to Evaluate the Safety and Efficacy of Ropinirole in Motor Recovery After Stroke |
Estimated Enrollment: | 52 |
Study Start Date: | October 2003 |
Study Completion Date: | May 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Stroke is a leading cause of disability. Current treatments target injury and must be delivered within hours. A body of literature suggests that there are processes ongoing days-months after stroke that can be targeted therapeutically, and improve function. The current study evaluates one such potential therapy, the dopamine agonist ropinirole. The current study tests the hypothesis that patients with chronic stroke randomized to ropinirole+physiotherapy will show improved gait velocity over the 12 weeks of study participation as compared to patients randomized to placebo+physiotherapy. A secondary aim is to test the hypothesis that ropinirole will improve three secondary endpoints at 12 weeks after study entry: the proportion of patients with no significant disability (Barthel Index ≥ 95); overall motor status, measured with the arm/leg FM score; and overall physical function, defined as the score on the Stroke Impact Scale-16 (SIS-16). This study will also evaluate the safety of ropinirole in patients recovering from stroke.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, Irvine Medical Center | |
Orange, California, United States, 92868 |
Principal Investigator: | Steven C Cramer, MD | University of California, Irvine |
Responsible Party: | University of California, Irvine ( Steven C. Cramer, MD, MMSc ) |
Study ID Numbers: | HS#2003-3096 |
Study First Received: | September 19, 2005 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00221390 History of Changes |
Health Authority: | United States: Institutional Review Board |
stroke Chronic stroke with hemiparesis |
Neurotransmitter Agents Ropinirole Paresis Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Dopamine Agonists |
Brain Diseases Cerebrovascular Disorders Signs and Symptoms Dopamine Neurologic Manifestations Brain Ischemia Dopamine Agents Brain Infarction Infarction |
Neurotransmitter Agents Ropinirole Paresis Molecular Mechanisms of Pharmacological Action Cerebral Infarction Anti-Dyskinesia Agents Physiological Effects of Drugs Stroke Nervous System Diseases Vascular Diseases Antiparkinson Agents Central Nervous System Diseases |
Dopamine Agonists Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Signs and Symptoms Therapeutic Uses Neurologic Manifestations Brain Ischemia Dopamine Agents Cardiovascular Diseases Brain Infarction Central Nervous System Agents |