Clinical trial NCT03159000: A Research Study of Greater Occipital Nerve Block as a Treatment for Acute Migraine Attacks
Official title: Double-Blind, Placebo Controlled Trial of Greater Occipital Nerve Block for the Treatment of Migraine Attacks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of subjects experiencing headache improvement at 2 hours
timeFrame: 2 hours
Secondary outcomes:
measure: Percentage of subjects experiencing headache improvement 10 minutes
timeFrame: 10 minutes
measure: Percentage of subjects experiencing headache improvement at 30 minutes
timeFrame: 30 minutes
measure: Percentage of subjects experiencing headache improvement at 1 hour
timeFrame: 1 hour
measure: Percentage of subjects experiencing headache improvement at 24 hours
timeFrame: 24 hours
measure: Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes
timeFrame: 10 minutes
measure: Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes
timeFrame: 30 minutes
measure: Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour
timeFrame: 1 hour
measure: Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours
timeFrame: 2 hours
measure: Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: William B Young, MD
role: PRINCIPAL_INVESTIGATOR
References: