Treatment Response Among Chinese Neuromyelitis Optica Spectrum Disorders (Momentum)

October 15, 2019 updated by: Wei Qiu, Third Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • Wei Qiu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Acute episode of Neuromyelitis Optica Spectrum Disorders (NMOSD)

Description

1. Inclusion criteria for patients with baseline data collection:

  1. The subject can fully understand the content of the study and voluntarily sign the informed consent form;
  2. Male or female ≥18 years old;
  3. Diagnosed as NMOSD based on 2015 NMOSD diagnostic criteria of International NMO Diagnostic Team (IPND) and currently under acute attack.

2. Inclusion criteria for subjects enrolled in a prospective study cohort should further meet:

  1. The subject can fully understand the content of the study and voluntarily sign the informed consent form;
  2. Male or female,≥18 years old;
  3. Diagnosed as NMOSD based on 2015 NMOSD diagnostic criteria of International NMO Diagnostic Team (IPND) and currently under acute attack.
  4. Subjects with acute attack (including first episodes and relapse) should have an EDSS of ≥ 2 at baseline; and for patients with acute relapse, new symptoms or the primary symptoms, being judged by investigator, should have been aggravated for 24 hours or more [11-13];
  5. The subject should have typical symptoms of movement, sensation, vision, defecation/urination or nausea/vomiting at attack;
  6. Subjects should agree to participate in the study, and to receive AQP4-IgG examination before and after treatment;
  7. Subjects should agree to undergo an ophthalmologic examination before and after treatment;
  8. Subjects should agree to participate the study and agree to have the collected data analyzed by this study.

3. Exclusion criteria:

  1. Subjects treated with study medication in another clinical trial during the last 30 days or 5 half-life periods prior to screening or during the effect period of the drug, whichever is the longest; Note: Subjects who participated in an observational study (ie, the study did not require changes to medication or other interventions) were not excluded.
  2. Immediate relatives of the researcher/research center staff directly related to the study, or the researcher/research center staff directly related to the study ("immediate relatives" refer to spouses, parents, children or siblings (Whether it's biological or legal adoption).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expansile Disability Status Score
Time Frame: 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.
at the end of the first high-dose intravenous Methylprednisone (IVMP) therapy (up to 3 weeks )among subjects who received high-dose IVMP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expansile Disability Status Score
Time Frame: at discharge (7 days after last treatment)
Compared with baseline, proportion of subjects with EDSS improved ≥1 point at discharge (7 days after last treatment)
at discharge (7 days after last treatment)
Changes In AQP4-IgG
Time Frame: at the end of the first IVMP therapy（up to 3 weeks) among subjects who received high-dose IVMP
Compared with baseline , changes in AQP4-IgG at the end of the first IVMP therapy among subjects who received high-dose IVMP
at the end of the first IVMP therapy（up to 3 weeks) among subjects who received high-dose IVMP
As Assessed By Snellen Chart
Time Frame: at the end of the first high-dose IVMP theraty (up to 3 weeks) among subjects who received high-dose IVMP
Compared with baseline , changes in visual acuity (as assessed by Snellen chart) at the end of the first high-dose IVMP therapy among subjects who received high-dose IVMP
at the end of the first high-dose IVMP theraty (up to 3 weeks) among subjects who received high-dose IVMP
PGI-I Score
Time Frame: at the end of the first high-dose IVMP therapy(up to 3 weeks) among subjects who received high-dose IVMP

Score of Patient Global Improvement-Impression (PGI-I) at the end of the first high-dose IVMP therapy among subjects who received high-dose IVMP Patient Global Impressions (PGI)-Improvement Mark the box that best describes how you (the patient) have felt in general since you started taking this medicine. (Choose one)

1 = Very assessed, 2 = Much better, 3 = A little better, 4 = The same, 5 = A little worse, 6 = Much worse, 7 = Very much worse
at the end of the first high-dose IVMP therapy(up to 3 weeks) among subjects who received high-dose IVMP
Changes In AQP4-IgG
Time Frame: 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
at discharge (7 days after the last treatment)
As Assessed By Snellen Chart
Time Frame: 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
at discharge (7 days after the last treatment)
PGI-I Score
Time Frame: 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
at discharge (7 days after the last treatment)
Expansile Disability Status Score
Time Frame: 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
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)
Time Frame: 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)
at discharge (7 days after the last treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Collaborators

Nanfang Hospital of Southern Medical University
Second Affiliated Hospital of Guangzhou Medical University
Guangdong 999 Brain Hospital

Investigators

  • Principal Investigator: Wei Qiu, Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 21, 2019

Primary Completion (ANTICIPATED)

January 2, 2020

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

September 23, 2019

First Posted (ACTUAL)

September 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuromyelitis Optica Spectrum Disorders

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe