An interventional study of Lidocaine 2% and Methylprednisolone 80 mg and Placebo in Migraine Disorders, Medication Overuse Headache and Greater Occipital Nerve Block, sponsored by Mahidol University. Recruiting at 3 sites in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Mahidol University · Not applicable, Interventional, and Treatment
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 130 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive Greater Occipital Nerve Block (GONB) with 2% Lidocaine + methylprednisolone 80 mg
Drug: Lidocaine 2% and Methylprednisolone 80 mg
Participants receive occipital injection with Normal Saline (0.9% NaCl).
Other: Placebo
Drug page: Lidocaine
A 4-mL injection containing 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg). The injection is administered at the medial third of the distance between the external occipital protuberance and the mastoid process.
A 4-mL injection of 0.9% Normal Saline administered at the medial third of the distance between the external occipital protuberance and the mastoid process.
Percentage of patients with Medication Overuse Headache (MOH)
The percentage of participants diagnosed with Medication Overuse Headache (MOH) according to ICHD criteria.
Time frame: At the end of month 1 and month 3 after detoxification.
Percentage of patients achieving 50% improvement in migraine
The percentage of patients with at least a 50% reduction in monthly headache days compared to baseline (month -1).
Time frame: At the end of month 3.
Change in monthly headache days
The mean change in the number of headache days per month from baseline to month 3.
Time frame: Baseline (month -1) and month 3.
Change in mean headache severity
The change in mean headache severity scores measured by the Visual Analog Scale (VAS). 0 being no pain and 10 being the worst pain
Time frame: Baseline (month -1) and month 3.
Change in Migraine Disability Assessment (MIDAS) Score
Evaluation of the change in disability caused by migraines using the MIDAS questionnaire. MIDAS score ranges from 0 to 270 with the higher score, the worse disability.
Time frame: Baseline (month -1) and month 3.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Lidocaine