Greater Occipital Nerve Block for Migraine Prophylaxis - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00915473

Purpose

The purpose of this study is to determine whether greater occipital nerve block injection reduces the frequency of migraine headaches.

Condition	Intervention	Phase
Migraine Headache	Drug: bupivicaine/methylprednisolone (Active Injection) Drug: Placebo Injection	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Greater Occipital Nerve Block for Migraine Prophylaxis

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Bupivacaine hydrochloride Bupivacaine Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

The primary outcome measure is whether the patient had at least 50% reduction in the frequency of days with moderate or severe migraine. [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	June 2009
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active Active greater occipital nerve block injection.	Drug: bupivicaine/methylprednisolone (Active Injection) 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the greater occipital nerve.
Placebo Comparator: Placebo Placebo greater occipital nerve block injection.	Drug: Placebo Injection 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the greater occipital nerve.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-75 years.
ICHD-II episodic or chronic migraine.
At least 1 attack per week.

Exclusion Criteria:

Pregnant or lactating.
Continuous headache.
Maintenance opioid medication.
Started migraine prophylactic medication within the past 2 months.
Hypersensitivity to study ingredients.
Investigational medication within 90 days of screening.
Injection site infection at injection visit.
Systemic infection at injection visit.
Cranial bone defect.
Chronic cluster headache, new daily persistent headache, hemicrania continua, or chronic tension type headache.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915473

Contacts

Contact: Teri Radam

480-342-3409

radam.teresa@mayo.edu

Locations

United States, Arizona
Mayo Clinic	Recruiting
Phoenix, Arizona, United States, 85054
Contact: Teri Radam 480-342-3409 radam.teresa@mayo.edu
Principal Investigator: David W. Dodick, M.D.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

David W. Dodick, M.D.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	David W. Dodick M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00915473 History of Changes
Other Study ID Numbers:	08-008203
Study First Received:	June 5, 2009
Last Updated:	November 10, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Bupivacaine
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate

Prednisolone
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012