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

This study is not yet open for participant recruitment.
Verified February 2016 by Jakob Møller Hansen, MD., Danish Headache Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02686983
First Posted: February 22, 2016
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jakob Møller Hansen, MD., Danish Headache Center
  Purpose
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 Intervention Phase
Chronic Migraine Drug: Betamethasone and local anesthetic Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jakob Møller Hansen, MD., Danish Headache Center:

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


Estimated Enrollment: 34
Study Start Date: March 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Contact: Jakob Møller Hansen jamoha01@regionh.dk

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

Responsible Party: Jakob Møller Hansen, MD., MD, PhD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02686983     History of Changes
Other Study ID Numbers: DHC-GON-1
First Submitted: February 12, 2016
First Posted: February 22, 2016
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:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics
Anesthetics, Local
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
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