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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Individuals under 18 years of age

Inability to provide informed consent for the prospective cohort

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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).

Time frame
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

Time frame
From 31 march to 30 december 2026

Secondary outcomes

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.

Time frame
From March, 31 2026 to December, 30 2026

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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