Gabapentin's Effects on Insomnia in Patients With Recent Concussion

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.

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Key information

Conditions

Insomnia Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Dyssomnias Head Injuries, Closed Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University at Buffalo, Concussion Clinic

Buffalo, New York, 14214, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

Treatment and study plan

Gabapentin

Drug

300mg capsules by mouth

Primary outcomes

Change in Insomnia Severity Index from Baseline to 1 week

Time frame: 1 week

Secondary outcomes

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

Time frame: 1 week

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: Aug 22, 2011
Registry last updated: Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed