Amphetamine-Enhanced Stroke Recovery

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Amphetamine; Dextroamphetamine

Criteria

Inclusion Criteria:

1. Documented (including neuroimaging) ischemic hemispheric stroke

2. Start treatment between 10-30 days after stroke

3. Independent prior to index stroke (Rankin 0 or 1)

4. Moderate or severe stroke-related motor impairment (Fugl-Meyer motor score <80)

5. Patient (or legal representative) capable of giving informed consent

6. Availability for follow-up evaluation

7. Physically able to receive study drug/ placebo

Exclusion Criteria:

1. 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

2. Index or remote intracerebral or subarachnoid hemorrhage

3. History of or active psychosis or bipolar disorder

4. Angina pectoris within the preceding 3 months

5. Myocardial infarction within the preceding year

6. Inducible myocardial ischemia based on exercise or pharmacological stress test if done within the prior year

7. Clinically significant congestive heart failure defined as New York Heart Class 3 or 4

8. 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

9. History of seizures or seizures associated with index ischemic stroke

10. Allergy to amphetamine

11. Current treatment with L-dopa, other dopamine agonist, or MAO inhibitor

12. Glaucoma

13. 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)

14. Hyperthyroidism

15. Pregnancy

16. Expected rehabilitation stay less than 3 weeks for regimen 1

17. Mild stroke-related motor impairment (Fugl-Meyer motor score >80).

18. Participation in another investigational protocol

19. Any condition which in the view of the investigator would put the patient at risk through their participation in the study.