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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1

Details

• Lead Sponsor: Craig Hospital
• Collaborator: U.S. Department of Education
• Treatments: Armodafinil; Modafinil

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