This is a """"""""Pilot Grant"""""""" which proposes to collect preliminary data in order to help in the design of a full scale clinical trail testing the efficacy of amphetamine in conjunction with physical therapy to facilitate motor recovery after stroke. This clinical study will incorporate five sites including, Duke University, Burke Rehabilitation Hospital, Helen Hayes Hospital, Wake Forest University and Washington University. Under the direction of Dr. Goldstein, this pilot proposal is designed to refine the amphetamine-physical therapy as well as the targeted patient population. In addition, the proposed work will help in the estimation for appropriate sample size, refine outcome measures, monitoring techniques, patient protocols and data management procedures. Finally, the completion of this pilot study would result in data addressing the efficacy of this treatment strategy. Patients will be randomized for either amphetamine or placebo during 10-30 days after stroke. The initial design will incorporate a treatment of 10-mg d-amphetamine or placebo combined with a one-hour physical therapy session beginning one hour after drug/placebo administration every 4 days for a total of 6 sessions. Analyzing the first 65 patients, a second cohort of patients will then be entered into a different regimen depending on whether the first regimen suggests a benefit of this combined therapy. If the data are supported, the second regiment will consist of 10 mg of d-amphetamine or placebo combined with a one-hour physical therapy session as in the first regimen, but the interval between treatments will be decreased to very 2 days. If the initial data is not supportive, the second regimen will consist of treatments with 10 mg of d-amphetamine or placebo combined with a one-hour physical therapy session beginning one hour after drug/placebo administration every 4 days. However the treatment duration will be increased to a total of 10 sessions.
| Goldstein, Larry B (2009) Amphetamine trials and tribulations. Stroke 40:S133-5 |
