Text Size

Gabapentin's Effects on Insomnia in Patients With Recent Concussion

This study is currently recruiting participants.
Verified August 2011 by University at Buffalo
Sponsor:
Information provided by (Responsible Party):
Thomas Guttuso, University at Buffalo
ClinicalTrials.gov Identifier:
NCT01421264
First received: August 16, 2011
Last updated: August 19, 2011
Last verified: August 2011
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • Change in Insomnia Severity Index from Baseline to 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Post Concussion Symptom Scale score from Baseline to 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin Drug: Gabapentin
300mg capsules by mouth

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421264

Contacts
Contact: Thomas Guttuso, MD 716-829-5454 tguttuso@buffalo.edu

Locations
United States, New York
University at Buffalo, Concussion Clinic Recruiting
Buffalo, New York, United States, 14214
Contact: John Leddy, MD     716-204-3200     leddy@buffalo.edu    
Sponsors and Collaborators
University at Buffalo
  More Information

No publications provided

Responsible Party: Thomas Guttuso, Assistant Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT01421264     History of Changes
Other Study ID Numbers: NEU3280611A
Study First Received: August 16, 2011
Last Updated: August 19, 2011
Health Authority: Safety Monitor USA:

Keywords provided by University at Buffalo:
concussion
gabapentin
neurontin
insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
 Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 16, 2013