Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233090
Status:
TERMINATED
Last Update Posted:
2016-04-15
First Post:
2005-10-03
Brief Title:
Post-Traumatic Brain Injury Post-TBI Fatigue and Its Treatment
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Post-TBI Fatigue and Its Treatment
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized clinical trial of modafinil vs placebo for treatment of fatigue after TBI
Detailed Description:
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 eg cognitive function 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
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 eg cognitive function 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H133A020501 | None | None | None |