Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury - Tabular View

Tracking Information
First Received Date ^ICMJE	June 18, 2008
Last Updated Date	June 19, 2008
Start Date ^ICMJE	October 2002
Primary Completion Date	March 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 19, 2008)	Self report of fatigue Self report of EDS Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00702637 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 19, 2008)	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)
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury
Official Title ^ICMJE	Modafinil for the Treatment of Fatigue and Excessive Daytime Sleepiness in Individuals With Traumatic Brain Injury
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.
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 number of those who survive TBI: fatigue and EDS. Need for Research: Modafinil has been shown to be useful for fatigue and sleepiness in patients with depression, multiple sclerosis, Parkinson's disease and individuals with EDS secondary to a variety of sleep disturbances. However, there has not been any controlled evaluation of Modafinil use for the treatment of individuals with TBI to date. Current and Future Research Activity: Approximately 60 participants with post-TBI fatigue will be randomly assigned to two 10-week periods of taking either Modafinil or placebo. Participants taking Modafinil during the first 10 weeks will be switched to placebo for the second 10 weeks. Similarly, participants taking placebo during the first 10 weeks will be switched to Modafinil for the second 10 weeks. Outcomes relating to fatigue and EDS will be collected weekly throughout the study. Other outcomes (including general health, depression, and cognitive function) will be collected at the start of each period, 4 weeks into each period, and again at the end of each period. It is hypothesized that participants taking Modafinil will report significantly less fatigue and EDS, report significantly better general health and depression scores, and perform significantly better on tests of cognitive performance in comparison to participants taking placebo.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Condition ^ICMJE	Fatigue
Intervention ^ICMJE	Drug: Modafinil
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	March 2005
Primary Completion Date	March 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00702637
Responsible Party	Alan Weintraub, MD, Craig Hospital
Study ID Numbers ^ICMJE	H133A020510; R01
Study Sponsor ^ICMJE	Craig Hospital
Collaborators ^ICMJE	National Institute of Disability and Rehabilitation Research
Investigators ^ICMJE
Information Provided By	Craig Hospital
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP