Clinic Registry Study of Optic Neuromyelitis Spectrum Disease in China

NMO Spectrum Disorder;Registry Study Clinical Trial

Official title:

Clinic Registry Study of Optic Neuromyelitis Spectrum Disease in China

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03514030
• Other study ID #: 2018-2
• Status: Enrolling by invitation
• Start date: April 1, 2018
• Est. completion date: April 2021

Study information

• Verified date: April 2018
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: April 2021
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromyelitis Optica
• NMO Spectrum Disorder;Registry Study

Intervention

Diagnostic Test:
• serum AQP4-antibody testing method
there are different methods of testing serum AQP4-antibody

Locations

Country	Name	City	State
China	Beijing Tongren Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	misdiagnosis rate	misdiagnosis rate of NMOSD	3 years