Gabapentin's Effects on Insomnia in Patients With Recent Concussion

This study is currently recruiting participants.

Verified August 2011 by University at Buffalo

Sponsor:

Information provided by (Responsible Party):

Thomas Guttuso, University at Buffalo

ClinicalTrials.gov Identifier:

NCT01421264

First received: August 16, 2011

Last updated: August 19, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 16, 2011

Last Updated Date

August 19, 2011

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Insomnia Severity Index from Baseline to 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01421264 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in Post Concussion Symptom Scale score from Baseline to 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Gabapentin's Effects on Insomnia in Patients With Recent Concussion

Official Title ^ICMJE

Not Provided

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Insomnia

Intervention ^ICMJE

Drug: Gabapentin

300mg capsules by mouth

Study Arm (s)

Experimental: Gabapentin

Intervention: Drug: Gabapentin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Gender

Both

Ages

14 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Thomas Guttuso, MD

716-829-5454

tguttuso@buffalo.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01421264

Other Study ID Numbers ^ICMJE

NEU3280611A

Has Data Monitoring Committee

Responsible Party

Thomas Guttuso, University at Buffalo

Study Sponsor ^ICMJE

University at Buffalo

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

University at Buffalo

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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