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Clinical Trials/NCT01421264
NCT01421264CompletedPhase 1

Gabapentin's Effects on Insomnia in Patients With Recent Concussion

State University of New York at Buffalo1 site in 1 country21 target enrollmentStarted: August 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Change in Insomnia Severity Index from Baseline to 1 week
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
14 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 >
  • •PCSS score at Baseline >
  • •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

  • Not provided

Arms & Interventions

Gabapentin

Experimental

Intervention: Gabapentin (Drug)

Outcomes

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(1 week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Guttuso

Assistant Professor

State University of New York at Buffalo

Study Sites (1)

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