A Phase 1 interventional study of Modafinil in Fatigue, sponsored by Craig Hospital. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-06-14.
Sponsored by Craig Hospital · Phase 1, Interventional, and Treatment
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.
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.
1,912 studies on the registry are indexed under Fatigue; 381 are open to participants now.
This study's enrollment of 60 is above the median of 53 across 1,479 interventional studies indexed under Fatigue.
Browse Fatigue studies →Craig Hospital is the lead sponsor of 38 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Self report of fatigue
Self report of EDS
Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)
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)
No study locations are listed for this record.
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Modafinil
Craig Hospital