GON-block in Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study (DHC-GON-1)
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| ClinicalTrials.gov Identifier: NCT02686983 |
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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
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Sponsor:
Jakob Møller Hansen, MD.
Information provided by (Responsible Party):
Jakob Møller Hansen, MD., Danish Headache Center
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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 |
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 (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
| Arm | Intervention/treatment |
|---|---|
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Experimental: Active
Betamethasone and local anesthetic.
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Drug: Betamethasone and local anesthetic
Infiltration of the greater occipital nerve .
Other Name: GON block |
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Placebo Comparator: Placebo
Saline with local anesthetic.
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Drug: Betamethasone and local anesthetic
Infiltration of the greater occipital nerve .
Other Name: GON block |
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
Information from the National Library of Medicine
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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
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 |
| 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 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 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 |