Clinic Registry Study of Optic Neuromyelitis Spectrum Disease in China

• Conditions: NMO Spectrum Disorder;Registry Study
• Interventions: Diagnostic Test: serum AQP4-antibody testing method

• Registration Number: NCT03514030
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

In 1894, Devic first proposed the concept of neuromyelitis optica(NMO). NMO is an inflammatory demyelinating disease that selectively affects the central nervous system of the optic nerve and spinal cord.In 2004, Lennon and other persons found highly specific AQP4（aquaporin 4）antibodies in NMO patients'sera, and further differentiated between NMO and MS, confirming that NMO is an independent disease.At present, NMO has been widely recognized as an idiopathic and severe demyelinating disease of the central nervous system.In 2015, the international NMO diagnostic team developed the diagnostic criteria based on highly specific AQP4 antibodie.Up to now, in China, there is no data on the number of NMOSD patients, the rate of misdiagnosis, the treatment methods, and the prognosis.This study is committed to build China's NMOSD big data platform to provide the basis for diagnosis, treatment and prognosis of the disease.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-04
• Study Start: 2018-04-01
• Study First Submitted: 2018-04-20
• Study First Submitted QC: 2018-04-20
• Last Update Submitted: 2018-04-20
• Study First Posted: 2018-05-02
• Last Update Posted: 2018-05-02
• Primary Completion: 2020-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. more than 14 years old
2. Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015

Exclusion Criteria

1. less than 14 years old
2. NOT Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
negtive	serum AQP4-antibody testing method	serum AQP4-antibody is negtive
positive	serum AQP4-antibody testing method	serum AQP4-antibody is positive

Primary Outcome Measures

Name	Time	Method
misdiagnosis rate	3 years	misdiagnosis rate of NMOSD

Trial Locations

Locations (1)

Beijing Tongren Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China