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Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02330094
First Posted: January 1, 2015
Last Update Posted: October 18, 2017
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):
William D. Freeman, Mayo Clinic
  Purpose
The purpose of this study is to see how much gabapentin will reduce headaches associated with subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication prescribed.

Condition Intervention Phase
Aneurysmal Subarachnoid Hemorrhage Drug: Gabapentin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by William D. Freeman, Mayo Clinic:

Primary Outcome Measures:
  • Reduction in daily average numeric pain score from baseline using Visual Analogue Scale [ Time Frame: 7 days ]
  • Total daily narcotic consumption [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Treatment related adverse events [ Time Frame: 7 days ]
  • Pain control satisfaction questionnaire [ Time Frame: 7 days ]

Enrollment: 14
Study Start Date: December 2014
Study Completion Date: September 1, 2017
Primary Completion Date: September 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin
Gabapentin capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Drug: Gabapentin

Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.

Both groups will receive other standard of care pain medications.

Other Name: Neurontin
Placebo Comparator: Control
Placebo capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Drug: Placebo

Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.

Both groups will receive other standard of care pain medications.


Detailed Description:
We plan to use gabapentin (GBP), an FDA approved non-narcotic pain medication for neuropathic pain, which is also an alpha-2-delta (A2DR) receptor analogue to reduce the pain and decrease the need for narcotics in patients with aneurysmal subarachnoid hemorrhage (aSAH). GBP has been shown to decrease neuropathic and non-neuropathic pain in a variety of perioperative and postoperative conditions. A2DR affinity also has some neuroprotective effect in animal data. We plan to conduct a prospective, double-blinded, randomized trial to further assess GBP-associated reductions in narcotic use and pain scores compared to the non-GBP (placebo) arm. To accomplish this aim, we plan to randomize 20 aSAH patients with headache to either GBP and standard of care pain treatment versus placebo and standard of care treatment.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Have aneurysmal subarachnoid hemorrhage (aSAH) diagnosed by CT scan of the brain and/or angiogram evidence of intracranial aneurysm (CTA or digital subtraction angiogram or MRA)
  3. Have symptomatic headache
  4. Able to swallow and verbalize pain score
  5. No known allergy to gabapentin or fentanyl
  6. Numeric pain score ≥ 5
  7. Ability to provide written personal consent

Exclusion Criteria:

  1. Gabapentin use prior to SAH admission
  2. Renal failure with creatinine clearance less than 30 mL/min
  3. Unable to receive standard of care pain medications
  4. Pregnant or breastfeeding patients
  5. History of severe depression defined by DSM IV
  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): NCT02330094


Locations
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: William Freeman, MD Mayo Clinic
  More Information

Responsible Party: William D. Freeman, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02330094     History of Changes
Other Study ID Numbers: 14-005288
First Submitted: December 24, 2014
First Posted: January 1, 2015
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by William D. Freeman, Mayo Clinic:
aSAH
SAH

Additional relevant MeSH terms:
Hemorrhage
Headache
Subarachnoid Hemorrhage
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
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