Treatment Response Among Chinese Neuromyelitis Optica Spectrum Disorders

• Conditions: Neuromyelitis Optica Spectrum Disorders

• Registration Number: NCT04101058
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

Neuromyelitis Optica (NMO)/ Neuromyelitis Optica Spectrum Disorders (NMOSD) is an immune-mediated inflammatory demyelinating disease of the central nervous system mainly involving optic nerve and spinal cord. It is clinically characterized by simultaneous or sequential involvement of the optic nerve and spinal cord, presenting a progressive or remission and relapse course, which can lead to paralysis and blindness.

The objective of this study is to provide evidence regarding treat effects and factors related to prognosis which will help physicians better evaluable risk-benefit in NMOSD management and improve patients' outcome.

Detailed Description

Neuromyelitis Optica (NMO)/ Neuromyelitis Optica Spectrum Disorders (NMOSD) is an immune-mediated inflammatory demyelinating disease of the central nervous system mainly involving optic nerve and spinal cord. It is clinically characterized by simultaneous or sequential involvement of the optic nerve and spinal cord, presenting a progressive or remission and relapse course, which can lead to paralysis and blindness.

Globally, there is no solid data available for the diagnosis, treatment and prognosis of patients with acute Neuromyelitis Optica Spectrum Disorders (NMOSD) attack, particularly very rare data from prospective studies. This is a multicenter, prospective, real-world cohort study in patients with acute NMOSD attack in China.

Baseline data for approximately 200 patients with acute NMOSD attack from approximately 4 centers will be collected. Patients with acute NMOSD attack (including first episodes and relapses) whose expansile disability status score (EDSS ) ≥ 2 points at baseline will be eligible to be further included in prospective study cohort for analysis of treatment effects and prognosis.

The objective of this study is to provide evidence regarding treat effects and factors related to prognosis which will help physicians better evaluable risk-benefit in NMOSD management and improve patients' outcome.

Study Timeline

• Study First Submitted: 2018-12-14
• Study Start: 2019-01-21
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-24
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17
• Primary Completion: 2020-01-02
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expansile Disability Status Score	at the end of the first high-dose intravenous Methylprednisone (IVMP) therapy (up to 3 weeks )among subjects who received high-dose IVMP	Compared with baseline, changes in EDSS（Expansile Disability Status Score ）at the end of the first high-dose intravenous Methylprednisone (IVMP) therapy among subjects who received high-dose IVMP.; EDSS score is based on the evaluation of eight functional systems of the central nervous system.The total score of the assessment is between 0 and 10 points, and each 0.5 is divided into one grade, which is divided into 20 grades.

Secondary Outcome Measures

Name	Time	Method
Expansile Disability Status Score	at discharge (7 days after the last treatment)	Compared with baseline, changes in EDSS at discharge (7 days after the last treatment) \* among subjects who received high-dose IVMP
Changes In AQP4-IgG	at discharge (7 days after the last treatment)	Compared with baseline , changes in AQP4-IgG at discharge (7 days after the last treatment) \* among subjects who received high-dose IVMP
The proportion of patients who did not respond to the first high-dose IVMP therapy(up to 3 weeks)	at discharge (7 days after the last treatment)	The proportion of patients who did not respond to the first high-dose IVMP therapy(up to 3 weeks)
As Assessed By Snellen Chart	at discharge (7 days after the last treatment)	Compared with baseline, changes in visual acuity (as assessed by Snellen chart) at discharge (7 days after the last treatment)\* among subjects who received high-dose IVMP
PGI-I Score	at discharge (7 days after the last treatment)	Score of Patient Global Improvement-Impression (PGI-I) at discharge (7 days after the last treatment)\* among subjects who received high-dose IVMP

Trial Locations

Locations (1)

Wei Qiu; 🇨🇳 Guangzhou, China