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

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ClinicalTrials.gov Identifier: NCT02686983

Recruitment Status : Unknown

Verified February 2016 by Jakob Møller Hansen, MD., Danish Headache Center.
Recruitment status was: Not yet recruiting

First Posted : February 22, 2016

Last Update Posted : February 23, 2016

Sponsor:

Information provided by (Responsible Party):

Jakob Møller Hansen, MD., Danish Headache Center

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.

Condition or disease	Intervention/treatment	Phase
Chronic Migraine	Drug: Betamethasone and local anesthetic	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	34 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Greater Occipital Nerve Blockade for the Treatment of Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study
Study Start Date :	March 2016
Estimated Primary Completion Date :	March 2018
Estimated Study Completion Date :	July 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Betamethasone

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active Betamethasone and local anesthetic.	Drug: Betamethasone and local anesthetic Infiltration of the greater occipital nerve . Other Name: GON block
Placebo Comparator: Placebo Saline with local anesthetic.	Drug: Betamethasone and local anesthetic Infiltration of the greater occipital nerve . Other Name: GON block

Outcome Measures

Primary Outcome Measures :

Number of migraine days [ Time Frame: 8 weeks ]
Number of days fulfilling the ICHD criteria for migraine

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic migraine

Exclusion Criteria:

Medication overuse headache

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686983

Contacts

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Contact: Jakob Møller Hansen		jamoha01@regionh.dk

Locations

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

Sponsors and Collaborators

Jakob Møller Hansen, MD.

Investigators

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

More Information

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Responsible Party:	Jakob Møller Hansen, MD., MD, PhD, Danish Headache Center
ClinicalTrials.gov Identifier:	NCT02686983
Other Study ID Numbers:	DHC-GON-1
First Posted:	February 22, 2016 Key Record Dates
Last Update Posted:	February 23, 2016
Last Verified:	February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

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Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Betamethasone Anesthetics Anesthetics, Local Central Nervous System Depressants	Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Respiratory System Agents

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