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Gabapentin's Effects on Insomnia in Patients With Recent Concussion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01421264
First Posted: August 22, 2011
Last Update Posted: June 24, 2013
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.
Information provided by (Responsible Party):
Thomas Guttuso, University at Buffalo
  Purpose
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 Intervention Phase
Insomnia Drug: Gabapentin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Thomas Guttuso, University at Buffalo:

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

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

Enrollment: 21
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin Drug: Gabapentin
300mg capsules by mouth

  Eligibility

Information from the National Library of Medicine

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

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:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01421264


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

Responsible Party: Thomas Guttuso, Assistant Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT01421264     History of Changes
Other Study ID Numbers: NEU3280611A
First Submitted: August 16, 2011
First Posted: August 22, 2011
Last Update Posted: June 24, 2013
Last Verified: June 2013

Keywords provided by Thomas Guttuso, University at Buffalo:
concussion
gabapentin
neurontin
insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
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