Status:
TERMINATED
Post-Traumatic Brain Injury (Post-TBI) Fatigue and Its Treatment
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Fatigue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.
Detailed Description
Purpose: The purpose of this study is to examine the efficacy of the drug modafinil as a treatment for fatigue post TBI. Background: After TBI, fatigue is one of the most common complaints, as docume...
Eligibility Criteria
Inclusion
- \- Individuals who sustained a TBI with a documented loss of consciousness or evidence of a TBI on neuroimaging studies and who are at least 12 months post-injury, who complain of fatigue and who have scores of 22 or above on the Barroso Fatigue Scale will be eligible to participate in this study. Subjects must not meet criteria for alcohol or substance abuse using the Structured Clinical Interview for DSM-IV (SCID) for at least six months prior to study enrollment.
Exclusion
- \- Diagnosis of chronic neurological disease (including Lyme disease), narcolepsy, current infectious disease, chronic fatigue syndrome, fibromyalgia, anemia, hypothyroidism not adequately controlled with medication, blood pressure greater 150/100 mm Hg, or clinically significant major systemic disease. In addition, individuals taking medications which are known to cause fatigue will be excluded from participation in the study.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00233090
Start Date
July 1 2005
End Date
December 1 2008
Last Update
April 15 2016
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574