Fatigue Clinical Trial
Official title:
Modafinil for the Treatment of Fatigue and Excessive Daytime Sleepiness in Individuals With Traumatic Brain Injury
Verified date | June 2010 |
Source | Craig Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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) improving cognitive function and quality of life in individuals with TBI.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2005 |
Est. primary completion date | March 2005 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Craig Hospital | U.S. Department of Education |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self report of fatigue | |||
Primary | Self report of EDS | |||
Primary | Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study) | |||
Secondary | Self report of general health | |||
Secondary | Self report of depressive symptomatology | |||
Secondary | Performance on tests of cognitive functioning | |||
Secondary | Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study) |
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