GON-block in Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study

Phase 4

• Conditions: Chronic Migraine
• Interventions: Drug: Betamethasone and local anesthetic

• Registration Number: NCT02686983
• Lead Sponsor: Jakob Møller Hansen, MD.

Brief Summary

Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. Corticosteroids may be helpful in reducing the pain intensity and frequency in chronic migrtaine. This RCT is set up to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Detailed Description

Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. In general, there is a marked paucity of evidence concerning GON blocks in migraine. Corticosteroids may be helpful in reducing the pain intensity and frequency in these patients. This is an RCT to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Study Timeline

• Status Verified: 2016-02
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-22
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23
• Study Start: 2016-03
• Primary Completion: 2018-03
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Chronic migraine

Exclusion Criteria

• Medication overuse headache

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Betamethasone and local anesthetic	Saline with local anesthetic.
Active	Betamethasone and local anesthetic	Betamethasone and local anesthetic.

Primary Outcome Measures

Name	Time	Method
Number of migraine days	8 weeks	Number of days fulfilling the ICHD criteria for migraine

Secondary Outcome Measures

Name	Time	Method
Number of days with severe headache days	8 weeks	Number of days with severe headache days
Medication use	8 weeks	use of medication recorded during the 8 weeks
Responder rate	8 weeks	number of patients with more than 50% reduction in migraine
Number of migraine attacks	8 weeks	Number of attacks fulfilling the ICHD criteria for migraine

Trial Locations

Locations (1)

Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital; 🇩🇰 Glostrup, Copenhagen, Denmark