Gabapentin's Effects on Insomnia in Patients With Recent Concussion

Phase 1

Completed

• Conditions: Insomnia
• Interventions: Drug: Gabapentin

• Registration Number: NCT01421264
• Lead Sponsor: State University of New York at Buffalo

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 available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-22
• Primary Completion: 2012-12
• Study Completion: 2013-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gabapentin	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index from Baseline to 1 week	1 week

Secondary Outcome Measures

Name	Time	Method
Change in Post Concussion Symptom Scale score from Baseline to 1 week	1 week

Trial Locations

Locations (1)

University at Buffalo, Concussion Clinic; 🇺🇸 Buffalo, New York, United States