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| Sponsor: | Mount Sinai School of Medicine |
|---|---|
| Collaborator: |
U.S. Department of Education |
| Information provided by: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00233090 |
Purpose
Randomized clinical trail of modafinil vs. placebo for treatment of fatigue after TBI.
| Condition | Intervention | Phase |
|---|---|---|
|
Fatigue |
Drug: Modafinil Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Post-TBI Fatigue and Its Treatment |
| Enrollment: | 23 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Modafinil: Experimental
single dose of 200 mg. a day of modafinil for four weeks
|
Drug: Modafinil
single dose of 200 mg. a day of modafinil for four weeks
|
| Placebo: Placebo Comparator |
Drug: Placebo
daily dose of placebo for four weeks.
|
Purpose: The purpose of this study is to examine the efficacy of the drug modafinil as a treatment for fatigue post TBI.
Background: After TBI, fatigue is one of the most common complaints, as documented in our work and that of many other researchers. People with TBI experience fatigue that seems to them out of proportion to whatever work they are doing or effort they are making. Fatigue after TBI is associated with decreased participation in normal activities in the community and has been linked to depression.
Need for Research: Research on use of drugs to treat post-TBI fatigue is inadequate. While studies of fatigue in people with other chronic conditions suggest that modafinil helps relieve fatigue and has fewer side effects than some other drugs used in treating fatigue, the use of modafinil has not yet been tested in people with TBI.
Current and Future Research Activity: More than 100 men and women volunteers who complain of post-TBI fatigue will be randomly assigned to a 4-week period of taking modafinil or a placebo. At the beginning and end of the study, the severity of their fatigue and associated symptoms (e.g., cognitive fucniton, mood, pain, daytime sleepiness, sleep quality, health status) will be assessed, as well as their participation in activities and perceived quality of life. It is hypothesized that modafinil will reduce the symptoms of fatigue and will increase level of activity and perceived quality of life to a significantly greater extent than will the placebo.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Individuals who sustained a TBI with a documented loss of consciousness or evidence of a TBI on neuroimaging studies and who are at least 12 months post-injury, who complain of fatigue and who have scores of 22 or above on the Barroso Fatigue Scale will be eligible to participate in this study. Subjects must not meet criteria for alcohol or substance abuse using the Structured Clinical Interview for DSM-IV (SCID) for at least six months prior to study enrollment.
Exclusion Criteria:
- diagnosis of chronic neurological disease (including Lyme disease), narcolepsy, current infectious disease, chronic fatigue syndrome, fibromyalgia, anemia, hypothyroidism not adequately controlled with medication, blood pressure greater 150/100 mm Hg, or clinically significant major systemic disease. In addition, individuals taking medications which are known to cause fatigue will be excluded from participation in the study.
Contacts and Locations| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029-6574 | |
| Principal Investigator: | Wayne A Gordon, Ph.D. | Mount Sinai School of Medicine |
More Information
| Responsible Party: | Mount Sinai School of Medicine ( Wayne Gordon ) |
| Study ID Numbers: | 02-0677, H133A020501 |
| Study First Received: | October 3, 2005 |
| Last Updated: | December 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00233090 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Fatigue TBI brain injury Modafinil traumatic brain injury |
|
Signs and Symptoms Fatigue Therapeutic Uses Physiological Effects of Drugs Central Nervous System Stimulants |
Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Modafinil |
