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

Chronic Migraine Clinical Trial

— DHC-GON-1  

Official title:

Greater Occipital Nerve Blockade for the Treatment of Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02686983
• Other study ID #: DHC-GON-1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 12, 2016
• Last updated: February 22, 2016
• Start date: March 2016
• Est. completion date: July 2018

Study information

• Verified date: February 2016
• Source: Danish Headache Center
• Contact: Jakob Møller Hansen
• Email: jamoha01[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: July 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Chronic migraine

Exclusion Criteria:

• Medication overuse headache

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Drug:
• Betamethasone and local anesthetic
Infiltration of the greater occipital nerve .

Locations

Country	Name	City	State
Denmark	Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital	Glostrup, Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Jakob Møller Hansen, MD.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of migraine days	Number of days fulfilling the ICHD criteria for migraine	8 weeks	Yes
Secondary	Number of days with severe headache days	Number of days with severe headache days	8 weeks	No
Secondary	Medication use	use of medication recorded during the 8 weeks	8 weeks	No
Secondary	Responder rate	number of patients with more than 50% reduction in migraine	8 weeks	No
Secondary	Number of migraine attacks	Number of attacks fulfilling the ICHD criteria for migraine	8 weeks	No