Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury
Modafinil for the Treatment of Fatigue and Excessive Daytime Sleepiness in Individuals With Traumatic Brain Injury
1 other identifier
interventional
60
0 countries
N/A
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) improving cognitive function and quality of life in individuals with TBI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2002
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedJune 14, 2010
June 1, 2010
2.4 years
June 18, 2008
June 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Self report of fatigue
Self report of EDS
Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)
Secondary Outcomes (4)
Self report of general health
Self report of depressive symptomatology
Performance on tests of cognitive functioning
Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Craig Hospitallead
- U.S. Department of Educationcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 20, 2008
Study Start
October 1, 2002
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
June 14, 2010
Record last verified: 2010-06