Gabapentin's Effects on Insomnia in Patients With Recent Concussion
Overview[ - collapse ][ - ]
| Purpose | In this open-label, pilot study the investigators will be assessing gabapentin's effects on insomnia and other concussion-related symptoms in patients with a recent concussion experiencing insomnia. |
|---|---|
| Condition | Insomnia |
| Intervention | Drug: Gabapentin |
| Phase | Phase 1 |
| Sponsor | University at Buffalo |
| Responsible Party | University at Buffalo |
| ClinicalTrials.gov Identifier | NCT01421264 |
| First Received | August 16, 2011 |
| Last Updated | June 21, 2013 |
| Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 16, 2011 |
|---|---|
| Last Updated Date | June 21, 2013 |
| Start Date | August 2011 |
| Estimated Primary Completion Date | June 2013 |
| Current Primary Outcome Measures | Change in Insomnia Severity Index from Baseline to 1 week [Time Frame: 1 week] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Change in Post Concussion Symptom Scale score from Baseline to 1 week [Time Frame: 1 week] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Gabapentin's Effects on Insomnia in Patients With Recent Concussion |
|---|---|
| Official Title | Not Provided |
| Brief Summary | In this open-label, pilot study the investigators will be assessing gabapentin's effects on insomnia and other concussion-related symptoms in patients with a recent concussion experiencing insomnia. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Insomnia |
| Intervention | Drug: Gabapentin 300mg capsules by mouth |
| Study Arm (s) | Experimental: Gabapentin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 21 |
| Estimated Completion Date | June 2013 |
| Estimated Primary Completion Date | December 2012 |
| Eligibility Criteria | Inclusion Criteria: 1. Head trauma causing concussion with either no loss of consciousness (LOC) or LOC < 30 minutes within previous 2 weeks. 2. ISS score at Baseline of > 14. 3. PCSS score at Baseline > 5. 4. If brain imaging has been checked, there was no intracerebral hemorrhage noted. 5. Glasgow Coma Scale score of 15 at Baseline. 6. Age of at least 14 years old. 7. Has not taken gabapentin or pregabalin any time since concussion and has no history of intolerance to gabapentin or pregabalin. 8. Has not taken any sleeping pills for previous 2 nights and agrees not to take any for the next 2 weeks. Exclusion Criteria: |
| Gender | Both |
| Ages | 14 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01421264 |
|---|---|
| Other Study ID Numbers | NEU3280611A |
| Has Data Monitoring Committee | No |
| Information Provided By | University at Buffalo |
| Study Sponsor | University at Buffalo |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | June 2013 |
Locations[ + expand ][ + ]
| University at Buffalo, Concussion Clinic | Buffalo, New York, United States, 14214 |
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