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

Sponsor:	Craig Hospital
Collaborator:	U.S. Department of Education
Information provided by:	Craig Hospital
ClinicalTrials.gov Identifier:	NCT00702637

Purpose

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	Intervention	Phase
Fatigue	Drug: Modafinil	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Modafinil for the Treatment of Fatigue and Excessive Daytime Sleepiness in Individuals With Traumatic Brain Injury

Resource links provided by NLM:

MedlinePlus related topics: Fatigue Traumatic Brain Injury

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by Craig Hospital:

Primary Outcome Measures:

Self report of fatigue
Self report of EDS
Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)

Secondary Outcome Measures:

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)

Estimated Enrollment:	60
Study Start Date:	October 2002
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Alan Weintraub, MD, Craig Hospital
ClinicalTrials.gov Identifier:	NCT00702637 History of Changes
Other Study ID Numbers:	H133A020510; R01
Study First Received:	June 18, 2008
Last Updated:	June 10, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Craig Hospital:

Traumatic Brain Injury
Fatigue
Modafinil
Somnolence

Additional relevant MeSH terms:

Fatigue
Brain Injuries
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012