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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00702637
Recruitment Status : Completed
First Posted : June 20, 2008
Last Update Posted : June 14, 2010
U.S. Department of Education
Information provided by:
Craig Hospital

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.

Condition or disease Intervention/treatment Phase
Fatigue Drug: Modafinil Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Modafinil for the Treatment of Fatigue and Excessive Daytime Sleepiness in Individuals With Traumatic Brain Injury
Study Start Date : October 2002
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil

Primary Outcome Measures :
  1. Self report of fatigue
  2. Self report of EDS
  3. Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)

Secondary Outcome Measures :
  1. Self report of general health
  2. Self report of depressive symptomatology
  3. Performance on tests of cognitive functioning
  4. Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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
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Responsible Party: Alan Weintraub, MD, Craig Hospital Identifier: NCT00702637    
Other Study ID Numbers: H133A020510; R01
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: June 14, 2010
Last Verified: June 2010
Keywords provided by Craig Hospital:
Traumatic Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action