AzTrials
AzTrials

MOGADMOGHEADNCT07479212

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

An observational study of MOGAD and Migraine, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MOGAD, Migraine, Cephalalgia
How many people
25 participants
Where
No sites listed yet
Study dates
31 Mar 2026to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Massimiliano Mirabella, Associate Professor contact

+39 0630155390

massimiliano.mirabella@unicatt.it

About this study

Official title: Single-center Ambispective Observational Study to Evaluate the Prevalence and Phenotype of Headache in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGHEAD).

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?

Read more

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.

Read the detailed description

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) is an inflammatory demyelinating disorder of the central nervous system associated with antibodies directed against myelin oligodendrocyte glycoprotein (MOG). The clinical spectrum of the disease includes optic neuritis, transverse myelitis, acute disseminated encephalomyelitis, and less frequently cortical encephalitis or brainstem and cerebellar syndromes. While pain has increasingly been recognized as an important component of the disease burden, the clinical relevance of headache in this population has not been systematically characterized.

Headache may occur during acute inflammatory attacks or persist during the chronic phase of the disease. Different clinical presentations have been described, including migraine-like, orbital, and cervicogenic-like headaches. Moreover, some patients may have a history of primary headache disorders hat precede the onset of MOGAD. The relationship between headache and disease-specific biological or radiological features remains unclear. In particular, it is not yet established whether headache may represent an early manifestation of the disease, a symptom associated with inflammatory activity, or a clinical feature related to specific anatomical sites of central nervous system involvement.

This study is a monocentric ambispective observational study conducted at the Multiple Sclerosis Center and the Headache Clinic of Fondazione Policlinico A. Gemelli IRCCS. The study will include approximately 25 adult patients diagnosed with MOGAD according to the International MOGAD Panel proposed diagnostic criteria. Both retrospective and prospective data will be analyzed.

Clinical, laboratory, and neuroradiological information will be collected from medical records generated during routine clinical care. Data will be extracted from both paper and electronic medical charts and recorded in a password-protected database. Demographic variables will include age, sex, ethnicity, body mass index, and smoking status. Clinical variables will include comorbid autoimmune diseases, non-neurological comorbidities, age at disease onset, clinical presentation at onset (for example optic neuritis, acute disseminated encephalomyelitis, encephalitis, or myelitis), and disease course (monophasic or relapsing).

Detailed information regarding headache will be collected, including age at headache onset, temporal relationship with MOGAD diagnosis, headache phenotype, localization, duration, frequency, intensity, associated symptoms, and response to treatments. The presence of primary headache prior to the onset of MOGAD and its clinical evolution after the diagnosis will also be assessed.

Laboratory data will include anti-MOG antibody status and cerebrospinal fluid findings, particularly the presence or absence of oligoclonal bands. Neuroradiological variables will include magnetic resonance imaging findings of the brain and spinal cord, with particular attention to the anatomical location of inflammatory or demyelinating lesions.

The study will also explore potential associations between headache characteristics and disease-related factors, including laboratory biomarkers and neuroradiological features, in order to better define the clinical relevance of headache within the spectrum of MOGAD. The planned enrollment period is 12 months, with an overall study duration of 24 months.

Keywords
MOGAD, Pain, Headache
Medical subject headings
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, Migraine Disorders, Headache, Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From March, 31 2026 to December, 30 2026

  2. 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

    Measured: From 31 march to 30 december 2026

Secondary outcomes (1)
  1. Correlation between headache and laboratory and neuroimaging findings in MOGAD

    To analyze the relationship between headache and laboratory and neuroradiological findings, including specific sites of inflammatory/demyelinating involvement, anti-MOG antibody titers, and the presence or absence of oligoclonal bands in the cerebrospinal fluid.

    Measured: From March, 31 2026 to December, 30 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2026
  2. Study start31 Mar 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07479212
Sponsor's protocol ID
27123
Acronym
MOGHEAD
Status last verified
Mar 2026
First submitted
13 Mar 2026
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 30961531
  • 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.

    PubMed 32062443
  • 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.

    PubMed 33473247
  • 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.

    PubMed 39878785
  • 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.

    PubMed 34418402
  • 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.

    PubMed 36706773
  • 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.

    PubMed 37789888
  • 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.

    PubMed 31162318
  • Bianco A, Lucchini M, Sottani C, Cicia A, Cerulli F, Di Sante G, Bisurgi M, d'Angio J, Vollono C, Calabresi P, Mirabella M. Prevalence and Clinical Phenotypes of Headache in Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease: The MOGHEAD Study. Pain Res Manag. 2026;2026(1):e4241103. doi: 10.1155/prm/4241103.

    PubMed 42839699

Questions about this trial

What is this clinical trial studying?

An observational study of MOGAD and Migraine, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Massimiliano Mirabella, Associate Professor (+39 0630155390, massimiliano.mirabella@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of headache in patients with yelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) (time frame: From March, 31 2026 to December, 30 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07479212, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in