Status:
COMPLETED
Greater Occipital Nerve Block for Migraine Prophylaxis
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Migraine Headache
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Migraine is a common neurological condition that can be disabling, particularly if chronic. Greater occipital nerve (GON) block has been utilized for decades for the treatment of migraine in the absen...
Detailed Description
Migraine is a common disease with lifetime prevalence in women and men of 33% and 12% respectively. Chronic migraine affects 2% of the US population and is highly disabling. There are no FDA approved ...
Eligibility Criteria
Inclusion
- Subjects meet diagnostic criteria for episodic migraine or chronic migraine according to the International Headache Classification II (ICHD-II)
- Migraine sufferers who experience at least 1 attack per week
- Able to read and understand the requirements of the study, abide by any restrictions, and return for the required examinations
- Able and willing to sign an informed consent statement
- Subjects must be in generally good health as confirmed by medical history, medication review, baseline physical examination, vital signs and clinical laboratory evaluations.
Exclusion
- Subjects with continuous headache (no headache free periods)
- Subjects using maintenance opioid medication
- Subjects who have started a medication with prophylactic migraine efficacy within the past 2 months
- Known hypersensitivity or allergic reaction to any of study ingredients (lidocaine, bupivicaine, any local anesthetics, and corticosteroids) or betadine.
- Use of any investigational medication within 90 days of the initial screening visit and/or concurrent enrolment in an investigational study
- Injection site infection or systemic infection at the injection visit (afebrile at time of injection)
- Presence of cranial bone defect
- Subjects with chronic cluster headache, new daily persistent headache, hemicrania continua, or chronic tension type headache
- Subjects with a history of an unstable medical condition (e.g. cardiovascular, hepatic, renal, endocrine) that may impair their reliable participation in the study or necessitate the use of medications not permitted in this study
- Subjects with a history (within the past 6 months) of a major psychiatric disorder that in the opinion of the investigator may preclude the subject from completed the requirements of the study
- Female subjects who are pregnant or nursing
- Subjects with a history of drug or alcohol abuse within the past 2 years
- Subjects with a history of poor compliance with past drug therapies, as judged by the investigator.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00915473
Start Date
June 1 2009
End Date
January 1 2013
Last Update
March 20 2014
Active Locations (1)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054