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Gabapentin's Effects on Insomnia in Patients With Recent Concussion

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring concussion, gabapentin, neurontin, insomnia

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • University at Buffalo, Concussion Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gabapentin

Arm Description

Outcomes

Primary Outcome Measures

Change in Insomnia Severity Index from Baseline to 1 week

Secondary Outcome Measures

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

Full Information

First Posted
August 16, 2011
Last Updated
February 10, 2023
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT01421264
Brief Title
Gabapentin's Effects on Insomnia in Patients With Recent Concussion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
concussion, gabapentin, neurontin, insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
300mg capsules by mouth
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index from Baseline to 1 week
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change in Post Concussion Symptom Scale score from Baseline to 1 week
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Facility Information:
Facility Name
University at Buffalo, Concussion Clinic
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

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Gabapentin's Effects on Insomnia in Patients With Recent Concussion

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