Status:
COMPLETED
Gabapentin's Effects on Insomnia in Patients With Recent Concussion
Lead Sponsor:
State University of New York at Buffalo
Conditions:
Insomnia
Eligibility:
All Genders
14+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Head trauma causing concussion with either no loss of consciousness (LOC) or LOC \< 30 minutes within previous 2 weeks.
- ISS score at Baseline of \> 14.
- PCSS score at Baseline \> 5.
- If brain imaging has been checked, there was no intracerebral hemorrhage noted.
- Glasgow Coma Scale score of 15 at Baseline.
- Age of at least 14 years old.
- Has not taken gabapentin or pregabalin any time since concussion and has no history of intolerance to gabapentin or pregabalin.
- Has not taken any sleeping pills for previous 2 nights and agrees not to take any for the next 2 weeks.
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01421264
Start Date
August 1 2011
End Date
June 1 2013
Last Update
February 14 2023
Active Locations (1)
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1
University at Buffalo, Concussion Clinic
Buffalo, New York, United States, 14214