Migraine DisordersGONB_MOHNCT07568496
Greater Occipital Nerve Block for Migraine With Medication Overuse Headache
A study testing Lidocaine 2% and Methylprednisolone 80 mg in people with Migraine Disorders and Medication Overuse Headache, run by Mahidol University at 3 sites in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine Disorders, Medication Overuse Headache, Greater Occipital Nerve Block
- What is being tested?
- Lidocaine 2% and Methylprednisolone 80 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 3 sitesThailand
- Study dates
- 12 May 2026to 1 Nov 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand3 sites, 3 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
Pannathat Soontrapa, M.D., 662-4197101-2, pannathat.soo@mahidol.edu
Pannathat Soontrapa, M.D.
- Not yet recruiting
Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, 50200
Surat Tanprawate, M.D., 6683-2032103, surat.tan@cmu.ac.th
Surat Tanprawate, M.D.
- Recruiting
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
Prut Koonalintip, M.D., 6689-7846676, koo.prut@gmail.com
Prut Koonalintip, M.D.
About this study
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.
- Being tested
- Lidocaine 2% and Methylprednisolone 80 mg, Placebo
- Keywords
- GONB, Nerve Block, Detoxification, MOH, Methylprednisolone, Lidocaine
- Medical subject headings
- Migraine Disorders, Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% and Methylprednisolone 80 mgDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment (GONB) | Active comparator | Participants receive Greater Occipital Nerve Block (GONB) with 2% Lidocaine + methylprednisolone 80 mg Receives: Drug: Lidocaine 2% and Methylprednisolone 80 mg |
| Placebo group | Placebo comparator | Participants receive occipital injection with Normal Saline (0.9% NaCl). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with Medication Overuse Headache (MOH)
The percentage of participants diagnosed with Medication Overuse Headache (MOH) according to ICHD criteria.
Measured: At the end of month 1 and month 3 after detoxification.
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline (month -1) and month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start12 May 2026
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Chiang Mai University, Thailand, Prince of Songkla University, The Royal College of Physicians of Thailand
- Responsible party
- Principal investigator, Pannathat Soontrapa, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568496
- Sponsor's protocol ID
- Si321/2026
- Acronym
- GONB_MOH
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2023 Headache Collaborators. Global, regional, and national burden of headache disorders, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023. Lancet Neurol. 2025 Dec;24(12):1005-1015. doi: 10.1016/S1474-4422(25)00402-8.
PubMed 41240916Arab A, Khoshbin M, Karimi E, Saberian G, Saadatnia M, Khorvash F. Effects of greater occipital nerve block with local anesthetic and triamcinolone for treatment of medication overuse headache: an open-label, parallel, randomized, controlled clinical trial. Neurol Sci. 2022 Jan;43(1):549-557. doi: 10.1007/s10072-021-05295-y. Epub 2021 May 4.
PubMed 33945036Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl 1):S20-8. doi: 10.1212/wnl.56.suppl_1.s20.
PubMed 11294956Inan LE, Inan N, Unal-Artik HA, Atac C, Babaoglu G. Greater occipital nerve block in migraine prophylaxis: Narrative review. Cephalalgia. 2019 Jun;39(7):908-920. doi: 10.1177/0333102418821669. Epub 2019 Jan 6.
PubMed 30612462Chowdhury D, Tomar A, Deorari V, Duggal A, Krishnan A, Koul A. Greater occipital nerve blockade for the preventive treatment of chronic migraine: A randomized double-blind placebo-controlled study. Cephalalgia. 2023 Feb;43(2):3331024221143541. doi: 10.1177/03331024221143541.
PubMed 36739512Diener HC, Marmura MJ, Tepper SJ, Cowan R, Starling AJ, Diamond ML, Hirman J, Mehta L, Brevig T, Sperling B, Cady R. Efficacy, tolerability, and safety of eptinezumab in patients with a dual diagnosis of chronic migraine and medication-overuse headache: Subgroup analysis of PROMISE-2. Headache. 2021 Jan;61(1):125-136. doi: 10.1111/head.14036. Epub 2020 Dec 13.
PubMed 33314079Silberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z. The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain. 2020 Sep 21;21(1):114. doi: 10.1186/s10194-020-01173-8.
PubMed 32958075Dodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J, Dong Y, Pearlman EM. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021 Mar;41(3):340-352. doi: 10.1177/0333102420966658. Epub 2020 Nov 3.
PubMed 33143451Koonalintip P, Phillips K, Wakerley BR. Medication-Overuse Headache: Update on Management. Life (Basel). 2024 Sep 11;14(9):1146. doi: 10.3390/life14091146.
PubMed 39337929Gosalia H, Moreno-Ajona D, Goadsby PJ. Medication-overuse headache: a narrative review. J Headache Pain. 2024 May 31;25(1):89. doi: 10.1186/s10194-024-01755-w.
PubMed 38816828Vandenbussche N, Laterza D, Lisicki M, Lloyd J, Lupi C, Tischler H, Toom K, Vandervorst F, Quintana S, Paemeleire K, Katsarava Z. Medication-overuse headache: a widely recognized entity amidst ongoing debate. J Headache Pain. 2018 Jul 13;19(1):50. doi: 10.1186/s10194-018-0875-x.
PubMed 30003412Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Shand B, Goicochea MT, Valenzuela R, Fadic R, Jensen R, Tassorelli C, Nappi G; COMOESTAS CONSORTIUM. Clinical and Demographical Characteristics of Patients with Medication Overuse Headache in Argentina and Chile: Analysis of the Latin American Section of COMOESTAS Project. J Headache Pain. 2015;16:83. doi: 10.1186/s10194-015-0561-1. Epub 2015 Sep 18.
PubMed 26382855