Gabapentin's Effects on Insomnia in Patients With Recent Concussion

University at Buffalo (UB)

Status and phase: Completed; Phase 1

Conditions: Insomnia

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT01421264

NEU3280611A

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Gabapentin

Experimental group

Treatment:

Drug: Gabapentin