Trial of Ropinirole in Motor Recovery After Stroke

Completed

Phase 2 Results

Trial Description

The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke.

Detailed Description

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.

Conditions

Interventions

  • Physical therapy Other
  • Ropinirole (Requip and Ropark)Drug
    Intervention Desc: Ropinirole acts as an agonist at the D2 and D3 dopamine receptor subtypes, binding with higher affinity to D3 than to D2 or D4 and It has no affinity for D1 receptors. It has medium in vitro affinity to opioid receptors. Ropinirole is weakly active at the 5-HT2, and α2 receptors and is said to have virtually no affinity to 5-HT1, benzodiazepine, GABA, muscarinic, α1, and β-adrenoreceptors.[4]
  • Ropinirole (+ physical therapy) Drug
  • (vs.) Placebo + physical therapy Drug

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized (1:1) to ropinirole or placebo in a double-blind manner. Study drug will be administered over 9 weeks and will be gradually titrated from 0.25 mg QD to a maximum of 4 mg QD. All patients will receive about 20 hours of standardized leg and arm physiotherapy during the last four weeks of study drug treatment. A follow-up visit will be conducted 3 weeks after study drug is discontinued.

Outcomes

Type Measure Time Frame Safety Issue
Primary Gait velocity measured over 12 weeks of study participation.
Secondary Barthel Index; Leg motor Fugl-Meyer scale; Stroke Impact Scale-16; Gait endurance; Hamilton Depression Scale; Safety.
Secondary Barthel Index Measured at weeks 1, 9, and 12 Yes
Secondary Leg motor Fugl-Meyer scale Measured at baseline and weeks 1, 2, 4, 6, 7, 8, 9, and 12 Yes
Secondary Stroke Impact Scale-16 Measured at weeks 1, 4, 7, 9, and 12 Yes
Secondary Gait endurance Measured at weeks 1, 2, 4, 6, 7, 8, 9, and 12 Yes
Secondary Hamilton Depression Scale Measured at baseline and weeks 1, 2, 9, and 12 Yes
Secondary Safety 12 weeks Yes

Sponsors