Gabapentin's Effects on Insomnia in Patients With Recent Concussion

Insomnia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421264
• Other study ID #: NEU3280611A
• Status: Completed
• Phase: Phase 1
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Gabapentin
300mg capsules by mouth

Locations

Country	Name	City	State
United States	University at Buffalo, Concussion Clinic	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index from Baseline to 1 week		1 week
Secondary	Change in Post Concussion Symptom Scale score from Baseline to 1 week		1 week