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NCT Number: NCT07266051

Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)

This study aims to characterize sex hormone alterations and their potential clinical significance in NMOSD patients from Southern China through comprehensive hormonal profiling.

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Key information

Conditions

NMOSD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Xiamen university, Xiamen, Fujian, China

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About this study

This study is a prospective cohort study, aiming to explore the characteristics of sex hormone levels in patients with neuromyelitis optica spectrum disorder (NMOSD). It plans to include 2,000 patients with NMOSD and 2,000 healthy controls, and conduct a 3-year follow-up. By regularly collecting data such as serum sex hormone levels, imaging, neurological function scales, and various biomarkers, the differences between the two groups will be compared and analyzed to reveal the role of sex hormones in NMOSD and their association with disease activity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion Criteria for the NMOSD Patient Group

  • Aged 18 years or older, regardless of sex
  • Fulfilled the diagnostic criteria for Neuromyelitis Optica Spectrum Disorders as defined by the 2021 Chinese guidelines for the diagnosis and management of NMOSD
  • Seropositive for AQP4-IgG
  • Provided informed consent by the participant or their legal guardian

Inclusion criteria

for the Healthy Control Group

  • Aged 18 years or older, regardless of sex
  • Gender- and age-matched healthy individuals
  • Provided informed consent by the participant or their legal guardian

Exclusion criteria

  • Diagnosis of other serious systemic diseases (e.g., malignancy)
  • Presence of severe psychiatric disorders that would preclude compliance with study procedures and/or follow-up assessments
  • History of infectious pathologies of the central nervous system
  • Those with severe liver and kidney function impairment or dysfunction of other vital organs
  • Patients with other conditions that do not allow participation in clinical research
  • Patients allergic to gadolinium-DPTA
  • Patients with other conditions that do not allow participation in clinical research

Treatment and study plan

Sex hormone assay

Other

This study will explore and validate the characteristics of sex hormone levels in MNMOSD

Primary outcomes

  1. Variations in Serum Sex Hormones

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Yiming

CONTACT

[email protected]

+8615652385796

Sponsors and collaborators

Lead sponsor

Xiamen Hospital of Traditional Chinese Medicine

Other

Registry information

Acronym: NMOSD

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 5, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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