Gabapentin's Effects on Insomnia in Patients With Recent Concussion | NCT01421264 | Trialant
CompletedInterventionalPhase 1Updated Feb 14, 2023
Gabapentin's Effects on Insomnia in Patients With Recent Concussion
ClinicalTrials.gov ID
NCT01421264
Lead Sponsor
State University of New York at BuffaloOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
21Actual
Last Update Posted
Feb 14, 2023Actual
Start Date
Aug 2011
Primary Completion Date
Dec 2012Actual
Completion Date
Jun 2013Actual
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.
Insomnia
Gabapentin
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.