Amphetamine-Enhanced Stroke Recovery

Completed

Phase 2 Results N/A

Eligibility 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.