NCT07568496 Greater Occipital Nerve Block for Migraine With Medication Overuse Headache
| NCT ID | NCT07568496 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Migraine Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2026-05-12 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Migraine is among the leading causes of disability worldwide. Inappropriate use of acute medications in the setting of primary headache, particularly migraine can result in a debilitating condition known as medication overuse headache (MOH). Treatment of MOH is challenging and the primary therapeutic approach is reducing painkillers which helps decrease the number of headache days. As a part of the detoxification process to discontinue acute medications, bridging therapy is often needed to reduce withdrawal headache. Currently, there are data supporting the use of greater occipital nerve block as a preventive treatment in chronic migraine, but no placebo-controlled trial has evaluated the efficacy of greater occipital nerve block in MOH. Therefore, this research aims to demonstrate the efficacy of greater occipital nerve block in detoxification of migraine patients with MOH. Patients will be recruited from Headache Clinic at 3 centers in Thailand from February 2026 to January 2028. After recruitment, patients will be randomized into 2 groups at a 1:1 ratio using a block of four, namely group A and B. A 5-mL syringe of 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg) will be prepared for each patient in group while a 5-mL syringe of 4 mL normal saline will be prepared for each patient in group B. Monthly headache days, duration, severity, acute medication type and number of usage days and relative headache status according to a 5-point Likert scale will be investigated at the 2 weeks, 1st, 2nd and 3rd month, MIDAS at the end of 3rd month.
Eligibility Criteria
Inclusion Criteria: * Patients who have a diagnosis of migraine with medication overuse headache according to ICHD-3 criteria confirmed by a neurologist * Female patients will be screened for pregnancy planning and married female patients must undergo a urine pregnancy test Exclusion Criteria: * Patients who have other types of headache disorders other than migraine * Patients who have a previous history of allergy to corticosteroid or lidocaine * Patients who had previous skull surgery * Pregnant women * Patients with a history of uncontrolled depression, or psychosis * Patients who get or plan to get CGRP-targeted therapies or botulinum toxin injection * Patients with an increased risk of bleeding or underlying bleeding disorders
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07568496 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Migraine Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07568496 currently recruiting?
Yes, NCT07568496 is actively recruiting participants. Contact the research team at pannathat.soo@mahidol.ac.th for enrollment information.
Where is the NCT07568496 trial being conducted?
This trial is being conducted at Bangkok, Thailand, Hat Yai, Thailand, Chiang Mai, Thailand.
Who is sponsoring the NCT07568496 clinical trial?
NCT07568496 is sponsored by Mahidol University. The trial plans to enroll 130 participants.
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