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

Migraine Clinical Trial

Official title:

Double-Blind, Placebo Controlled Trial of Greater Occipital Nerve Block for the Treatment of Migraine Attacks

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03159000
• Other study ID #: GON/WBY/003
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2021
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Saline
1ml of 1/3 saline

Combination Product:
• lidocaine/bupivacaine
1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects experiencing headache improvement at 2 hours	Headache intensity on 4 point pain scale from moderate or severe to mild or none	2 hours
Secondary	Percentage of subjects experiencing headache improvement 10 minutes	Headache intensity on 4 point pain scale from moderate or severe to mild or none.	10 minutes
Secondary	Percentage of subjects experiencing headache improvement at 30 minutes	Headache intensity on 4 point pain scale from moderate or severe to mild or none.	30 minutes
Secondary	Percentage of subjects experiencing headache improvement at 1 hour	Headache intensity on 4 point pain scale from moderate or severe to mild or none.	1 hour
Secondary	Percentage of subjects experiencing headache improvement at 24 hours	Headache intensity on 4 point pain scale from moderate or severe to mild or none.	24 hours
Secondary	Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes	Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia	10 minutes
Secondary	Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes	Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia	30 minutes
Secondary	Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour	Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia	1 hour
Secondary	Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours	Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia	2 hours
Secondary	Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours	Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia	24 hours