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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00702637 |
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Date of registration:
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18/06/2008 |
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Primary sponsor: |
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Public title:
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Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury
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Scientific title:
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Modafinil for the Treatment of Fatigue and Excessive Daytime Sleepiness in Individuals With Traumatic Brain Injury |
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Date of first enrolment:
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October 2002 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00702637 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fatigue
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Intervention(s)
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Drug: Modafinil
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Primary Outcome(s)
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Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)
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Self report of EDS
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Self report of fatigue
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Secondary Outcome(s)
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Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)
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Performance on tests of cognitive functioning
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Self report of depressive symptomatology
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Self report of general health
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Secondary ID(s)
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H133A020510; R01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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