A pilot, comparison study of the treatment in acute attack of neuromyelitisoptica: Intravenous methylprednisolone versus plasma exchange alone

Phase 1

Recruiting

• Conditions: Motor power grade ≤ 2 Medical research council for first attackAt least 2- point worsening in 1 of the pyramidal of functional system score (FSS) compared to last visitAt least 1- point worsening; neuromyelitis optica spectrum disorder; NMOSD; plasma exchange; intravenous methylprednisolone

• Registration Number: TCTR20160314002
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-14
• Study Completion: 2017-01-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Diagnosis of neuromyelitis optica/neruomyelitis optica spectrum disorder
Admit at siriraj hospital during 2016-2017
Diagnosis of acute severe attack of NMO within 30 days
Severe attack was defined at least one of the following
Motor power grade ≤ 2 Medical research council for first attack
At least 2-point worsening in 1 of the pyramidal of functional system score (FSS) compared to last visit
At least 1-point worsening in EDSS score compared to last visit if previous EDSS score is 5.5 or more
Visual acuity ≤ 20/200 one eye
Glascow coma scale < 6
Hemodynamic instability or respiratory failure

Exclusion Criteria

Previous treatment with intravenous steroid
Time to next relapse shorter than 90 days
Serious / uncontrolled infection
Hemodynamic unstable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement of neurological outcome at discharge and 6 months Expended disability status scale

Secondary Outcome Measures

Name	Time	Method
side effect of treatment during the admission, 1 month, 3 months and 3 months side effect