AESR
Amphetamine Enhanced Stroke Recovery Trial
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Status:
As of November 2005, 97 patients had been enrolled. As of 2/4/09, this trial is on hold pending application for continued funding. We have not closed it, and the data remain un-analyzed.
Purpose:
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.
Location(s):
North Carolina, Missouri, New York
Year Started:
2003
Design:
Multicenter, two-part, block-randomized, placebo-controlled pilot trial.
Inclusion Criteria
Patients with motor deficits resulting from hemispheric ischemic stroke.
Patient Involvement:
Part I: N = 65
Patients 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 = 65
Patients will also be block-randomized into treatment and control groups. Dosages will be dependent on data obtained in Part 1.
Primary Outcome:
Improvement in the Fugl-Meyer Motor score and evaluation of several secondary measures.
Results:
The premature withdrawal rate is less than half of predicted. There have been no serious, treatment-related complications.
Source of Information:
Presented at the 30th International Stroke Conference [February 2005].
Correspondence with trial coordinator [July 2005].
Presented at the 2006 International Stroke Conference [February 2006].
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Web Links and Publications:
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This information last updated on: 2/4/2009
Reviewed on: 02/04/2009.
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