Status:
COMPLETED
Amphetamine-Enhanced Stroke Recovery
Lead Sponsor:
Duke University
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 a...
Detailed Description
The purpose of this Pilot Grant is to collect data critical for the design of a subsequent full-scale clinical trial testing the efficacy of treatment with amphetamine combined with physical therapy t...
Eligibility Criteria
Inclusion
- Documented (including neuroimaging) ischemic hemispheric stroke
- Start treatment between 10-30 days after stroke
- Independent prior to index stroke (Rankin 0 or 1)
- Moderate or severe stroke-related motor impairment (Fugl-Meyer motor score \<80)
- Patient (or legal representative) capable of giving informed consent
- Availability for follow-up evaluation
- Physically able to receive study drug/ placebo
Exclusion
- Hypertension defined as systolic BP\>160, or diastolic BP\>100 mmHg at rest determined by 3 readings during the 24 hours prior to randomization. Patients with such elevations of blood pressure on admission who respond to antihypertensive medication before medication phase of the study is to start will be eligible to participate
- Index or remote intracerebral or subarachnoid hemorrhage
- History of or active psychosis or bipolar disorder
- Angina pectoris within the preceding 3 months
- Myocardial infarction within the preceding year
- Inducible myocardial ischemia based on exercise or pharmacological stress test if done within the prior year
- Clinically significant congestive heart failure defined as New York Heart Class 3 or 4
- Atrial or ventricular arrhythmias including atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, and Wolff Parkinson White by history, electrocardiogram, or Holter monitor if done
- History of seizures or seizures associated with index ischemic stroke
- Allergy to amphetamine
- Current treatment with L-dopa, other dopamine agonist, or MAO inhibitor
- Glaucoma
- Need for treatment with a drug/class thought to impair recovery based on laboratory and available clinical evidence (a1-adrenergic receptor antagonist, a2-adrenergic receptor agonist, benzodiazepine, dopamine receptor antagonist, phenobarbital, phenytoin)
- Hyperthyroidism
- Pregnancy
- Expected rehabilitation stay less than 3 weeks for regimen 1
- Mild stroke-related motor impairment (Fugl-Meyer motor score \>80).
- Participation in another investigational protocol
- Any condition which in the view of the investigator would put the patient at risk through their participation in the study.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01905371
Start Date
April 1 2001
End Date
June 1 2007
Last Update
July 23 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710