Post-Traumatic Brain Injury (Post-TBI) Fatigue and Its Treatment

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Fatigue

In brief

Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.

Key facts

Study ID

NCT00233090

Run by

Icahn School of Medicine at Mount Sinai

People needed

21

Starts

2005-07-01

Expected to finish

2008-12-01

Last updated by the study team

2016-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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