Back to resultsGON-block in Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study (DHC-GON-1)
Primary Purpose
Chronic Migraine
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Betamethasone and local anesthetic
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Migraine
Eligibility Criteria
Inclusion Criteria:
- Chronic migraine
Exclusion Criteria:
- Medication overuse headache
Sites / Locations
- Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Betamethasone and local anesthetic.
Saline with local anesthetic.
Outcomes
Primary Outcome Measures
Number of migraine days
Number of days fulfilling the ICHD criteria for migraine
Secondary Outcome Measures
Number of days with severe headache days
Number of days with severe headache days
Medication use
use of medication recorded during the 8 weeks
Responder rate
number of patients with more than 50% reduction in migraine
Number of migraine attacks
Number of attacks fulfilling the ICHD criteria for migraine
Full Information
NCT ID
NCT02686983
First Posted
February 12, 2016
Last Updated
February 22, 2016
Sponsor
Jakob Møller Hansen, MD.
1. Study Identification
Unique Protocol Identification Number
NCT02686983
Brief Title
GON-block in Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study
Acronym
DHC-GON-1
Official Title
Greater Occipital Nerve Blockade for the Treatment of Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jakob Møller Hansen, MD.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Betamethasone and local anesthetic.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline with local anesthetic.
Intervention Type
Drug
Intervention Name(s)
Betamethasone and local anesthetic
Other Intervention Name(s)
GON block
Intervention Description
Infiltration of the greater occipital nerve .
Primary Outcome Measure Information:
Title
Number of migraine days
Description
Number of days fulfilling the ICHD criteria for migraine
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of days with severe headache days
Description
Number of days with severe headache days
Time Frame
8 weeks
Title
Medication use
Description
use of medication recorded during the 8 weeks
Time Frame
8 weeks
Title
Responder rate
Description
number of patients with more than 50% reduction in migraine
Time Frame
8 weeks
Title
Number of migraine attacks
Description
Number of attacks fulfilling the ICHD criteria for migraine
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic migraine
Exclusion Criteria:
Medication overuse headache
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jakob Møller Hansen
Email
jamoha01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob M Hansen, MD, PhD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital
City
Glostrup, Copenhagen
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
GON-block in Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study
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