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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropinirole (+ physical therapy) | Drug | |||
| (vs.) Placebo + physical therapy | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Barthel Index | Measured at weeks 1, 9, and 12 | |
| Leg motor Fugl-Meyer scale | Measured at baseline and weeks 1, 2, 4, 6, 7, 8, 9, and 12 | |
| Stroke Impact Scale-16 | Measured at weeks 1, 4, 7, 9, and 12 | |
| Gait endurance | Measured at weeks 1, 2, 4, 6, 7, 8, 9, and 12 | |
| Hamilton Depression Scale | Measured at baseline and weeks 1, 2, 9, and 12 | |
| Safety | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven C Cramer, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Gresham GE, Duncan PW, Stason WB, Adams HP, Adelman AM, Alexander DN, Bishop DS, Diller L, Donaldson NE, Granger CV, Holland AL, Kelly-Hayes M, McDowell FH, Myers L, Phipps MA, Roth EJ, Siebens HC, Tarvin GA, Trombly CA. Post-Stroke Rehabilitation. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service, Agency for Health Care Policy and Research, 1995. | ||
| 12411667 | Background | Rathore SS, Hinn AR, Cooper LS, Tyroler HA, Rosamond WD. Characterization of incident stroke signs and symptoms: findings from the atherosclerosis risk in communities study. Stroke. 2002 Nov;33(11):2718-21. doi: 10.1161/01.str.0000035286.87503.31. | |
| Background | Dobkin BH. Neurologic Rehabilitation. Philadelphia: FA Davis, 1996 | ||
| 10607636 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C046649 | ropinirole |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Background |
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| 19520987 | Derived | Cramer SC, Dobkin BH, Noser EA, Rodriguez RW, Enney LA. Randomized, placebo-controlled, double-blind study of ropinirole in chronic stroke. Stroke. 2009 Sep;40(9):3034-8. doi: 10.1161/STROKEAHA.109.552075. Epub 2009 Jun 11. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |