Gabapentin's Effects on Insomnia in Patients With Recent Concussion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421264
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : June 24, 2013
Information provided by (Responsible Party):
Thomas Guttuso, University at Buffalo

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.

Condition or disease Intervention/treatment Phase
Insomnia Drug: Gabapentin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Gabapentin Drug: Gabapentin
300mg capsules by mouth

Primary Outcome Measures :
  1. Change in Insomnia Severity Index from Baseline to 1 week [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Change in Post Concussion Symptom Scale score from Baseline to 1 week [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421264

United States, New York
University at Buffalo, Concussion Clinic
Buffalo, New York, United States, 14214
Sponsors and Collaborators
University at Buffalo

Responsible Party: Thomas Guttuso, Assistant Professor, University at Buffalo Identifier: NCT01421264     History of Changes
Other Study ID Numbers: NEU3280611A
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013

Keywords provided by Thomas Guttuso, University at Buffalo:

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents