Greater Occipital Nerve Block for Migraine Prophylaxis

NCT00915473 | Completed Phase 4 Results

• 2 other identifiers: 08-008203UL1TR000135
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 absence of a single randomized, placebo-controlled trial documenting its effectiveness. Hypothesis: Greater occipital nerve block reduces the frequency of days with moderate or severe headache in patients with episodic or chronic migraine.

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period

  The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.

  4 weeks pre-injection baseline, 4 weeks post-injection

Secondary Outcomes (3)

• Mean Frequency of Days With a Migraine

  4 weeks post-injection

• Mean Number of Hours With Moderate or Severe Migraine

  4 weeks post-injection

• Mean Number of Days With Acute Medication Use

  4 weeks post-injection

Study Arms (2)

Active Injection

EXPERIMENTAL

Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.

Drug: bupivicaine; Drug: methylprednisolone

Placebo Injection

PLACEBO COMPARATOR

Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.

Drug: normal saline; Drug: lidocaine

Interventions

bupivicaine DRUG

2.5 mL 0.5% bupivicaine

Also known as: Marcain, Marcaine, Sensorcaine, Vivacaine

Active Injection

normal saline DRUG

2.75 mL normal saline

Placebo Injection

methylprednisolone DRUG

0.5 mL 20 mg methylprednisolone

Also known as: Medrol, Solu-Medrol

Active Injection

lidocaine DRUG

0.25 mL 1% lidocaine

Also known as: xylocaine

Placebo Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Related Publications (1)

• Dilli E, Halker R, Vargas B, Hentz J, Radam T, Rogers R, Dodick D. Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study. Cephalalgia. 2015 Oct;35(11):959-68. doi: 10.1177/0333102414561872. Epub 2014 Dec 12.

  PMID: 25505035 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Bupivacaine; Saline Solution; Methylprednisolone; Methylprednisolone Hemisuccinate; Lidocaine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides

Results Point of Contact

• Title: Dr. David Dodick
• Organization: Mayo Clinic

dodick.david@mayo.edu

480-301-5797

Study Officials

• David W. Dodick, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 8, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 20, 2014
• Results First Posted: February 25, 2014

Record last verified: 2014-02

Locations

US (1)