Gabapentin's Effects on Insomnia in Patients With Recent Concussion

NCT ID: NCT01421264

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gabapentin

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

300mg capsules by mouth

Interventions

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Gabapentin

300mg capsules by mouth

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Thomas Guttuso

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University at Buffalo, Concussion Clinic

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NEU3280611A

Identifier Type: -

Identifier Source: org_study_id

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