Headache Prevalence and Phenotype in Myelin Oligodendrocyte Glycoprotein Antibody -Associated Disease (MOGAD)

NCT07479212 | Not Yet Recruiting

• 1 other identifier: 27123
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) is an inflammatory demyelinating disorder of the central nervous system characterized by antibodies targeting myelin oligodendrocyte glycoprotein (MOG). Although the disease most commonly presents with optic neuritis, myelitis, or acute disseminated encephalomyelitis, headache has increasingly been reported as a potentially relevant and disabling symptom. However, the prevalence and clinical characteristics of headache in MOGAD remain poorly defined. The purpose of this monocentric ambispective observational study is to evaluate the prevalence and clinical phenotype of headache in adult patients with MOGAD. The study aims to answer the following research questions: How common is headache in patients with MOGAD, what are its clinical characteristics, and does it show any correlation with any specific disease features? The primary objective is to estimate the prevalence of acute and/or chronic headache in patients with MOGAD. Secondary objectives include describing headache characteristics (location, duration, intensity, associated symptoms, and response to treatment), assessing the presence and evolution of pre-existing primary headache disorders, and exploring potential associations between headache and laboratory or neuroradiological findings, including anti-MOG antibody titers, cerebrospinal fluid (CSF) oligoclonal bands, and the location of inflammatory or demyelinating lesions on MRI. Approximately 25 adult patients with MOGAD followed at the Multiple Sclerosis Center and Headache Clinic of the Fondazione Policlinico A. Gemelli IRCCS will be included. Clinical, laboratory, and neuroradiological data will be collected retrospectively and prospectively from medical records.

Conditions

MOGAD; Migraine; Cephalalgia

Keywords

MOGAD; Pain; Headache

Outcome Measures

Primary Outcomes (2)

• Prevalence of headache in patients with yelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

  To assess the prevalence of headache during the acute and/or chronic phase in a population of patients with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD).

  From March, 31 2026 to December, 30 2026

• Clinical characteristics of headache in patients with MOGAD

  To assess the clinical characteristics of headache during the acute and/or chronic phase in a population of patients with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, including location, duration, intensity, and associated symptoms at disease onset

  From 31 march to 30 december 2026

Secondary Outcomes (1)

• Correlation between headache and laboratory and neuroimaging findings in MOGAD

  From March, 31 2026 to December, 30 2026

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the Multiple Sclerosis Center and the Headache Clinic at Fondazione Policlinico A. Gemelli IRCCS who are diagnosed with MOGAD

You may qualify if:

• Patients older than 18 years with a diagnosis of Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) according to the International MOGAD Panel proposed criteria
• Ability to understand and provide written informed consent for the prospective cohort.

You may not qualify if:

• Individuals under 18 years of age
• Inability to provide informed consent for the prospective cohort

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Related Publications (8)

• Straube A, Andreou A. Primary headaches during lifespan. J Headache Pain. 2019 Apr 8;20(1):35. doi: 10.1186/s10194-019-0985-0.

  PMID: 30961531 RESULT

• Asseyer S, Hamblin J, Messina S, Mariano R, Siebert N, Everett R, Kuker W, Bellmann-Strobl J, Ruprecht K, Jarius S, Leite MI, U Brandt A, Paul F, Palace J. Prodromal headache in MOG-antibody positive optic neuritis. Mult Scler Relat Disord. 2020 May;40:101965. doi: 10.1016/j.msard.2020.101965. Epub 2020 Jan 25.

  PMID: 32062443 RESULT

• Asseyer S, Cooper G, Paul F. Pain in NMOSD and MOGAD: A Systematic Literature Review of Pathophysiology, Symptoms, and Current Treatment Strategies. Front Neurol. 2020 Aug 21;11:778. doi: 10.3389/fneur.2020.00778. eCollection 2020.

  PMID: 33473247 RESULT

• Diaz P, Nealon NE, Kaunzner UW. Pain and Headache in Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease. Curr Pain Headache Rep. 2025 Jan 29;29(1):39. doi: 10.1007/s11916-024-01322-7.

  PMID: 39878785 RESULT

• Marignier R, Hacohen Y, Cobo-Calvo A, Probstel AK, Aktas O, Alexopoulos H, Amato MP, Asgari N, Banwell B, Bennett J, Brilot F, Capobianco M, Chitnis T, Ciccarelli O, Deiva K, De Seze J, Fujihara K, Jacob A, Kim HJ, Kleiter I, Lassmann H, Leite MI, Linington C, Meinl E, Palace J, Paul F, Petzold A, Pittock S, Reindl M, Sato DK, Selmaj K, Siva A, Stankoff B, Tintore M, Traboulsee A, Waters P, Waubant E, Weinshenker B, Derfuss T, Vukusic S, Hemmer B. Myelin-oligodendrocyte glycoprotein antibody-associated disease. Lancet Neurol. 2021 Sep;20(9):762-772. doi: 10.1016/S1474-4422(21)00218-0.

  PMID: 34418402 RESULT

• Banwell B, Bennett JL, Marignier R, Kim HJ, Brilot F, Flanagan EP, Ramanathan S, Waters P, Tenembaum S, Graves JS, Chitnis T, Brandt AU, Hemingway C, Neuteboom R, Pandit L, Reindl M, Saiz A, Sato DK, Rostasy K, Paul F, Pittock SJ, Fujihara K, Palace J. Diagnosis of myelin oligodendrocyte glycoprotein antibody-associated disease: International MOGAD Panel proposed criteria. Lancet Neurol. 2023 Mar;22(3):268-282. doi: 10.1016/S1474-4422(22)00431-8. Epub 2023 Jan 24.

  PMID: 36706773 RESULT

• Hor JY, Fujihara K. Epidemiology of myelin oligodendrocyte glycoprotein antibody-associated disease: a review of prevalence and incidence worldwide. Front Neurol. 2023 Sep 15;14:1260358. doi: 10.3389/fneur.2023.1260358. eCollection 2023.

  PMID: 37789888 RESULT

• Flanagan EP. Neuromyelitis Optica Spectrum Disorder and Other Non-Multiple Sclerosis Central Nervous System Inflammatory Diseases. Continuum (Minneap Minn). 2019 Jun;25(3):815-844. doi: 10.1212/CON.0000000000000742.

  PMID: 31162318 RESULT

MeSH Terms

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; Migraine Disorders; Headache; Pain

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Immune System Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Massimiliano Mirabella, Associate Professor

CONTACT

+39 0630155390; massimiliano.mirabella@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share