Status:
COMPLETED
Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke
Lead Sponsor:
Burke Rehabilitation Hospital
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Stroke
Cerebrovascular Accident
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a relatively safe agent with interesting neurochemical effects on the catecholamine system, producing an improvem...
Eligibility Criteria
Inclusion
- First clinical stroke, either cerebral infarction or intracerebral hemorrhage
- Severe hemiparesis as measured by a Fugl-Meyer motor scale score of 0-25
- Screening Motricity Index score of 0-83
- Date of stroke onset between 7 to 21 days prior to study inclusion
Exclusion
- Age less than 18
- Previous clinical stroke
- Pregnant and/or nursing patients
- Major psychiatric history, including psychosis and history of substance abuse
- Dementia
- Known CNS pathology such as brain tumor
- Significant language dysfunction or severe neglect that hinders comprehension, participation, and barrier to testing
- Seizures
- Left ventricular hypertrophy (LVH)
- Mitral valve prolapse (MVP)
- Severe chronic renal failure or severe hepatic failure
- History or current use of anti-epileptic medications, psychostimulants, or neuroleptics
- Current use of diazepam, phenytoin, propranolol, tricyclic antidepressants, steroidal contraceptives, cyclosporine, or theophylline
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01896128
Start Date
January 1 2008
End Date
July 1 2015
Last Update
November 4 2019
Active Locations (1)
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1
The Burke Rehabilitation Hospital
White Plains, New York, United States, 10605