Amphetamine Enhanced Stroke Recovery Trial "AESR"

Suspended

Phase N/A Results

Trial Description

To collect data necessary to complete the design of a full-scale clinical trial that will compare the safety and efficacy of treatment with d-amphetamine in combination with physical therapy with that of physical therapy alone in facilitating poststroke motor recovery.

Interventions

Trial Design

Multicenter, two-part, block-randomized, placebo-controlled pilot trial.

Patient Involvement

Part I: N = 65Patients will be block-randomized (according to stroke severity and vascular distribution) into treatment and control groups. The treatment group will receive d-amphetamine 10 mg/day, while the control group will receive a placebo. Every 4 days, all patients will participate in a 1-hour physical therapy session beginning 1 hour after drug or placebo administration, for a total of 6 sessions.

Part II: N = 65Patients will also be block-randomized into treatment and control groups. Dosages will be dependent on data obtained in Part 1.

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement in the Fugl-Meyer Motor score and evaluation of several secondary measures.

Sponsors

National Institute for Neurological Disorders and Stroke, NIH