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

Craig Hospital

Status and phase

Completed

Phase 1

Conditions

Fatigue

Treatments

Drug: Modafinil

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00702637

H133A020510 R01;

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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