Clincosm LogoSign in Get a demo

Momentum: Treatment Response Among Chinese Neuromyelitis Optica Spectrum Disorders

Sponsor
Third Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04101058
Collaborator
Nanfang Hospital of Southern Medical University (Other), Second Affiliated Hospital of Guangzhou Medical University (Other), Guangdong 999 Brain Hospital (Other)
200
Enrollment
1
Location
17.3
Anticipated Duration (Months)
11.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Treatment Response Among Chinese Patients With Acute Attack of Neuromyelitis Optica Spectrum Disorders: A Prospective, Multicenter Real-world Study
    Actual Study Start Date :
    Jan 21, 2019
    Anticipated Primary Completion Date :
    Jan 2, 2020
    Anticipated Study Completion Date :
    Jun 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Expansile Disability Status Score [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)

    2. Changes In AQP4-IgG [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

    3. As Assessed By Snellen Chart [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

    4. PGI-I Score [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

    5. 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

    6. 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

    7. 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

    8. 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

    9. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    1. Inclusion criteria for patients with baseline data collection:

    2. The subject can fully understand the content of the study and voluntarily sign the informed consent form;

    3. Male or female ≥18 years old;

    4. Diagnosed as NMOSD based on 2015 NMOSD diagnostic criteria of International NMO Diagnostic Team (IPND) and currently under acute attack.

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

    6. The subject can fully understand the content of the study and voluntarily sign the informed consent form;

    7. Male or female,≥18 years old;

    8. Diagnosed as NMOSD based on 2015 NMOSD diagnostic criteria of International NMO Diagnostic Team (IPND) and currently under acute attack.

    9. 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];

    10. The subject should have typical symptoms of movement, sensation, vision, defecation/urination or nausea/vomiting at attack;

    11. Subjects should agree to participate in the study, and to receive AQP4-IgG examination before and after treatment;

    12. Subjects should agree to undergo an ophthalmologic examination before and after treatment;

    13. Subjects should agree to participate the study and agree to have the collected data analyzed by this study.

    14. Exclusion criteria:

    15. 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.

    16. 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wei Qiu Guangzhou China

    Sponsors and Collaborators

    • Third Affiliated Hospital, Sun Yat-Sen University
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Wei Qiu, Professor, Third Affiliated Hospital, Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT04101058
    Other Study ID Numbers:
    • 201809
    First Posted:
    Sep 24, 2019
    Last Update Posted:
    Oct 17, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuromyelitis Optica

    Study Results

    No Results Posted as of Oct 17, 2019