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NCT01905371 · ClinicalTrials.gov registry record · Phase 2
Amphetamine-Enhanced Stroke Recovery
A Phase 2 study of Stroke, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
- 1
- Study location
NCT01905371: Completed Phase 2 study of Stroke, sponsored by Duke University.
NCT01905371 is a Phase 2 study of Stroke that has completed, run by Duke University. The registered enrollment target is 99 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01905371, a Phase 2 study of Stroke, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The Fugl-Meyer score was determined at baseline, immediately after treatment, and 90 days poststroke in order to assess voluntary movement in both the upper and lower limbs using an ordinal scale. The mean change from baseline will be calculated at each timepoint for each study arm.
Conditions Studied
Interventions
- DRUG Placebo
- OTHER Physical Therapy
- DRUG Dextroamphetamine
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2001-04 |
| Est. Completion | 2007-06 |
| Phase | Phase 2 |
What the finished NCT01905371 record still lists
NCT01905371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01905371 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01905371 about?
NCT01905371 is a clinical study titled "Amphetamine-Enhanced Stroke Recovery". 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 inpat...
What is the current status of trial NCT01905371?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2001-04. Estimated completion is 2007-06.
What conditions does trial NCT01905371 study?
This clinical trial studies the following conditions: Stroke.
What interventions are being tested in trial NCT01905371?
The interventions under investigation include: Placebo (DRUG), Physical Therapy (OTHER), Dextroamphetamine (DRUG).
Who is sponsoring clinical trial NCT01905371?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01905371 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01905371's enrollment target sits among peer trials
99 147th of 454 higher than 307 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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