Status:
COMPLETED
Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury
Lead Sponsor:
Craig Hospital
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Fatigue
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether Modafinil is effective in: (1) reducing fatigue and excessive daytime sleepiness (EDS) in individuals with Traumatic Brain Injury (TBI); and (2) impro...
Detailed Description
Background: An estimated 5.3 million Americans are living with a TBI-related disability today. These persons may face many issues, however, two chronic problems seem common to a strikingly large numbe...
Eligibility Criteria
Inclusion
- Individuals who sustained a TBI
- were discharged from Craig Hospital following initial rehabilitation
- are at least one year post-injury
- have disabling symptoms of fatigue and/or EDS which compromise their ability to function optimally
- (if female) are surgically sterile, two years post-menopausal, or if of childbearing potential, are using a medially acceptable method of birth control and agree to continue use of this method for the duration of the study
Exclusion
- Individuals who have Neurologic and/or neuropsychiatric difficulties and/or deficits which will obscure the evaluation of this medication's effectiveness -
- have a diagnosis of other likely causes of EDS
- have concurrent medication use and/or clinically significant systemic disease that may cause fatigue and/or diminished arousal
- have epilepsy
- currently use of any anti-epileptic medications or Warfarin
- have cardiovascular disease or risks
- have severe renal or hepatic impairment
- have significant psychiatric or behavioral disturbance which would obscure the evaluation of medication effectiveness
- are a pregnant or lactating female
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00702637
Start Date
October 1 2002
End Date
March 1 2005
Last Update
June 14 2010
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