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A Research Study of Greater Occipital Nerve Block as a Treatment for Acute Migraine Attacks

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ClinicalTrials.gov Identifier: NCT03159000
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB. In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure. 50 subjects will be entered into this study. This study is being conducted at Thomas Jefferson University only.

Condition or disease Intervention/treatment Phase
Migraine Drug: Saline Combination Product: lidocaine/bupivacaine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo Controlled Trial of Greater Occipital Nerve Block for the Treatment of Migraine Attacks
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: GONB of lidocaine/bupivacaine
The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally. The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection. Subjects who are not improved after 2 hours will be allowed to use their abortive treatment.
Combination Product: lidocaine/bupivacaine
1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine
Placebo Comparator: Placebo injection of 1/3 saline
The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally. The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection. Subjects who are not improved after 2 hours will be allowed to use their abortive treatment.
Drug: Saline
1ml of 1/3 saline


Outcome Measures

Primary Outcome Measures :
  1. Percentage of subjects experiencing headache improvement at 2 hours [ Time Frame: 2 hours ]
    Headache intensity on 4 point pain scale from moderate or severe to mild or none


Secondary Outcome Measures :
  1. Percentage of subjects experiencing headache improvement 10 minutes [ Time Frame: 10 minutes ]
    Headache intensity on 4 point pain scale from moderate or severe to mild or none.

  2. Percentage of subjects experiencing headache improvement at 30 minutes [ Time Frame: 30 minutes ]
    Headache intensity on 4 point pain scale from moderate or severe to mild or none.

  3. Percentage of subjects experiencing headache improvement at 1 hour [ Time Frame: 1 hour ]
    Headache intensity on 4 point pain scale from moderate or severe to mild or none.

  4. Percentage of subjects experiencing headache improvement at 24 hours [ Time Frame: 24 hours ]
    Headache intensity on 4 point pain scale from moderate or severe to mild or none.

  5. Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes [ Time Frame: 10 minutes ]
    Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia

  6. Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes [ Time Frame: 30 minutes ]
    Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia

  7. Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour [ Time Frame: 1 hour ]
    Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia

  8. Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours [ Time Frame: 2 hours ]
    Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia

  9. Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours [ Time Frame: 24 hours ]
    Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling the international classification of headache disorders (ICHD3b) criteria for episodic migraine, presenting to clinic with an acute episodic migraine reported as at least a moderate pain level not lasting longer than 7 days at the time of injection.

Exclusion Criteria:

  • subjects who have received greater occipital nerve block (GONB) in the past, subjects who in their own or the investigator's opinion are unable to describe their symptoms, subjects who have are scheduled to receive injection of onabotulinum toxin A within 72 hours, subjects who are pregnant or lactating.
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): NCT03159000


Contacts
Contact: Kathleen Bradley, RN 215-955-2025 kathleen.bradley@jefferson.edu
Contact: Ashley Liautaud ashley.liautaud@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kathleen Bradley    215-955-2025    kathleen.bradley@jefferson.edu   
Principal Investigator: William Young, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: William B Young, MD Thomas Jefferson University
More Information

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03159000     History of Changes
Other Study ID Numbers: GON/WBY/003
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lidocaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action