NCT01421264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

August 16, 2011

Last Update Submit

February 10, 2023

Conditions

Insomnia

Keywords

concussiongabapentinneurontininsomnia

Outcome Measures

Primary Outcomes (1)

  • Change in Insomnia Severity Index from Baseline to 1 week

    1 week

Secondary Outcomes (1)

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

    1 week

Study Arms (1)

Gabapentin

EXPERIMENTAL
Drug: Gabapentin

Interventions

GabapentinDRUG

300mg capsules by mouth

Gabapentin

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo, Concussion Clinic

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersBrain Concussion

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBrain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 22, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

US(1)