NCT04101058

Treatment Response Among Chinese Neuromyelitis Optica Spectrum Disorders

Treatment Response Among Chinese Patients With Acute Attack of Neuromyelitis Optica Spectrum Disorders: A Prospective, Multicenter Real-world Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuromyelitis Optica Spectrum Disorders

Timeline

• Start date: 2019-01-21
• Primary completion: 2020-01-02
• Completion: 2020-06-30
• First posted: 2019-09-24
• Last updated: 2019-10-17

Locations

1 site across 1 country: China