drugset / Trial / NCT01905371

Amphetamine-Enhanced Stroke Recovery

NCT01905371 ↗

Phase 2 Completed 99 enrolled Duke University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is an NIH Pilot Clinical Trial Grant designed to provide data to permit the rationale design of a subsequent efficacy study. The purpose of this project is to determine the potential benefit of amphetamine combined with physical therapy in enhancing motor recovery in patients admitted for inpatient rehabilitation between 10 and 30 days after hemispheric ischemic stroke. The study hypotheses are: 1, The addition of treatment with d-amphetamine will result in at least a 12.6 point improvement in the Fugl-Meyer motor score 3 months after stroke. 2, There will be no clinically significant increase in the frequency of serious adverse events associated with treatment with d-amphetamine which would preclude further testing.

Timeline

Start
2001-04
Primary completion
2007-06
Completion
2007-06

Outcome

Missed primary endpoint

paper no overall treatment-associated difference in the mean (SEM) change in Fugl-Meyer motor scores from baseline to 3 months after stroke was noted PMID 30167675 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextroamphetamine Small molecule 10 mg —

Indications