Amphetamine-Enhanced Stroke Recovery

NCT01905371 | Completed Phase 2

• 1 other identifier: Pro00044966
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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 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

Stroke

Keywords

amphetamine; stroke recovery

Outcome Measures

Primary Outcomes (1)

• Mean Change in Fugl-Meyer Score from Baseline to 90 days Poststroke

  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.

  90 days, Baseline

Secondary Outcomes (7)

• Mean Change in Ambulation Speed Score from Baseline to 90 Days Poststroke

  90 days, Baseline

• Mean Change in Ambulation Endurance Score from Baseline to 90 days Poststroke

  90 days, Baseline

• Mean Change in the Action Research Arm Test (ARAT) score from Baseline to 90 days Poststroke

  90 days, Baseline

• Mean Change in the Mobility Subscale of the Functional Independence Measure from Baseline

  90 days, Baseline

• Mean Change in the NIH Stroke Scale Score from Baseline

  90 days, Baseline

Study Arms (2)

Dextroamphetamine + Physical therapy (PT)

EXPERIMENTAL

Treatment with d-amphetamine + physical therapy administered under two regimens administered sequentially: 10 mg of d-amphetamine combined with 1 hr PT session beginning 1 hr after drug administration every 4 days, for a total of 6 or 10 sessions

Drug: Dextroamphetamine; Other: Physical Therapy

Placebo + Physical Therapy (PT)

PLACEBO COMPARATOR

Treatment with placebo + physical therapy administered under two regimens administered sequentially: Regimen 1: 10 mg of placebo combined with 1 hr PT session beginning 1 hr after placebo administration every 4 days, for a total of 6 or 10 sessions

Other: Physical Therapy; Drug: Placebo

Interventions

Dextroamphetamine DRUG

Also known as: D-amphetamine

Dextroamphetamine + Physical therapy (PT)

Physical Therapy OTHER

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.

Dextroamphetamine + Physical therapy (PT); Placebo + Physical Therapy (PT)

Placebo DRUG

Placebo + Physical Therapy (PT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Goldstein LB, Lennihan L, Rabadi MJ, Good DC, Reding MJ, Dromerick AW, Samsa GP, Pura J. Effect of Dextroamphetamine on Poststroke Motor Recovery: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1494-1501. doi: 10.1001/jamaneurol.2018.2338.

  PMID: 30167675 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Dextroamphetamine; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Therapeutics; Rehabilitation

Study Officials

• Larry B Goldstein, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: April 1, 2001
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: July 23, 2013

Record last verified: 2013-07

Locations

US (1)