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

March 18, 2026 updated by: Mirabella Massimiliano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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?

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristics of headache in patients with MOGAD
Time Frame: From 31 march to 30 december 2026
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
Prevalence of headache in patients with yelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Time Frame: From March, 31 2026 to December, 30 2026
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between headache and laboratory and neuroimaging findings in MOGAD
Time Frame: From March, 31 2026 to December, 30 2026
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.
From March, 31 2026 to December, 30 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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