GON-block in Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study (DHC-GON-1)

February 22, 2016 updated by: Jakob Møller Hansen, MD.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Glostrup, Copenhagen, Denmark, 2600
        • Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic migraine

Exclusion Criteria:

  • Medication overuse headache

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Betamethasone and local anesthetic.
Drug: Betamethasone and local anesthetic
Infiltration of the greater occipital nerve .
Other Names:
  • GON block
Placebo Comparator: Placebo
Saline with local anesthetic.
Drug: Betamethasone and local anesthetic
Infiltration of the greater occipital nerve .
Other Names:
  • GON block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of migraine days
Time Frame: 8 weeks
Number of days fulfilling the ICHD criteria for migraine
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jakob Møller Hansen, MD.

Investigators

  • Principal Investigator: Jakob M Hansen, MD, PhD, Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHC-GON-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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