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Amphetamine-Enhanced Stroke Recovery

NCT01905371 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2013-07-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dextroamphetamine

OTHER

Physical Therapy

One hour of active physical therapy (PT) directed at a primary motor impairment. An outline indicating a range and level of physical therapy interventions will be provided to the therapists, and the level and of therapy will be recorded.

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Larry B Goldstein, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905371 on ClinicalTrials.gov