AzTrials
AzTrials

Neuromyelitis Optica Spectrum DisordersMomentumNCT04101058

Treatment Response Among Chinese Neuromyelitis Optica Spectrum Disorders

An observational study of Neuromyelitis Optica Spectrum Disorders, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuromyelitis Optica Spectrum Disorders
How many people
200 participants
Where
1 siteChina
Study dates
21 Jan 2019to 30 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Acute episode of Neuromyelitis Optica Spectrum Disorders (NMOSD)

  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).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Wei Qiu

    Guangzhou

Other trials in China

About this study

Official title: 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.

Read the 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.

Medical subject headings
Neuromyelitis Optica

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Expansile Disability Status Score

    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.

    Measured: at the end of the first high-dose intravenous Methylprednisone (IVMP) therapy (up to 3 weeks )among subjects who received high-dose IVMP

Secondary outcomes (9)

  1. Expansile Disability Status Score

    Compared with baseline, proportion of subjects with EDSS improved ≥1 point at discharge (7 days after last treatment)

    Measured: at discharge (7 days after last treatment)

  2. Changes In AQP4-IgG

    Compared with baseline , changes in AQP4-IgG at the end of the first IVMP therapy among subjects who received high-dose IVMP

    Measured: at the end of the first IVMP therapy（up to 3 weeks) among subjects who received high-dose IVMP

  3. As Assessed By Snellen Chart

    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

    Measured: at the end of the first high-dose IVMP theraty (up to 3 weeks) among subjects who received high-dose IVMP

  4. PGI-I Score

    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

    Measured: at the end of the first high-dose IVMP therapy(up to 3 weeks) among subjects who received high-dose IVMP

  5. Changes In AQP4-IgG

    Compared with baseline , changes in AQP4-IgG at discharge (7 days after the last treatment) * among subjects who received high-dose IVMP

    Measured: at discharge (7 days after the last treatment)

  6. As Assessed By Snellen Chart

    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

    Measured: at discharge (7 days after the last treatment)

  7. PGI-I Score

    Score of Patient Global Improvement-Impression (PGI-I) at discharge (7 days after the last treatment)* among subjects who received high-dose IVMP

    Measured: at discharge (7 days after the last treatment)

  8. Expansile Disability Status Score

    Compared with baseline, changes in EDSS at discharge (7 days after the last treatment) * among subjects who received high-dose IVMP

    Measured: at discharge (7 days after the last treatment)

  9. The proportion of patients who did not respond to the first high-dose IVMP therapy(up to 3 weeks)

    The proportion of patients who did not respond to the first high-dose IVMP therapy(up to 3 weeks)

    Measured: at discharge (7 days after the last treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2019
  2. Study start21 Jan 2019
  3. Primary completion2 Jan 2020 (estimated)
  4. Study completion30 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04101058
Sponsor's protocol ID
201809
Acronym
Momentum
Status last verified
Oct 2019
First submitted
14 Dec 2018
Last updated
17 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Papadopoulos MC, Bennett JL, Verkman AS. Treatment of neuromyelitis optica: state-of-the-art and emerging therapies. Nat Rev Neurol. 2014 Sep;10(9):493-506. doi: 10.1038/nrneurol.2014.141. Epub 2014 Aug 12.

    PubMed 25112508

  • Lennon VA, Kryzer TJ, Pittock SJ, Verkman AS, Hinson SR. IgG marker of optic-spinal multiple sclerosis binds to the aquaporin-4 water channel. J Exp Med. 2005 Aug 15;202(4):473-7. doi: 10.1084/jem.20050304. Epub 2005 Aug 8.

    PubMed 16087714

  • Kim SH, Kim W, Li XF, Jung IJ, Kim HJ. Repeated treatment with rituximab based on the assessment of peripheral circulating memory B cells in patients with relapsing neuromyelitis optica over 2 years. Arch Neurol. 2011 Nov;68(11):1412-20. doi: 10.1001/archneurol.2011.154. Epub 2011 Jul 11.

    PubMed 21747007

  • Bizzoco E, Lolli F, Repice AM, Hakiki B, Falcini M, Barilaro A, Taiuti R, Siracusa G, Amato MP, Biagioli T, Lori S, Moretti M, Vinattieri A, Nencini P, Massacesi L, Mata S. Prevalence of neuromyelitis optica spectrum disorder and phenotype distribution. J Neurol. 2009 Nov;256(11):1891-8. doi: 10.1007/s00415-009-5171-x. Epub 2009 May 28.

    PubMed 19479168

  • Kawachi I, Lassmann H. Neurodegeneration in multiple sclerosis and neuromyelitis optica. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):137-145. doi: 10.1136/jnnp-2016-313300. Epub 2016 Sep 26.

    PubMed 27671902

  • Pandit L, Asgari N, Apiwattanakul M, Palace J, Paul F, Leite MI, Kleiter I, Chitnis T; GJCF International Clinical Consortium & Biorepository for Neuromyelitis Optica. Demographic and clinical features of neuromyelitis optica: A review. Mult Scler. 2015 Jun;21(7):845-53. doi: 10.1177/1352458515572406. Epub 2015 Apr 28.

    PubMed 25921037

  • Optic Neuritis Study Group. Multiple sclerosis risk after optic neuritis: final optic neuritis treatment trial follow-up. Arch Neurol. 2008 Jun;65(6):727-32. doi: 10.1001/archneur.65.6.727.

    PubMed 18541792

  • Weinshenker BG, O'Brien PC, Petterson TM, Noseworthy JH, Lucchinetti CF, Dodick DW, Pineda AA, Stevens LN, Rodriguez M. A randomized trial of plasma exchange in acute central nervous system inflammatory demyelinating disease. Ann Neurol. 1999 Dec;46(6):878-86. doi: 10.1002/1531-8249(199912)46:63.0.co;2-q.

    PubMed 10589540

  • Kim SH, Kim W, Huh SY, Lee KY, Jung IJ, Kim HJ. Clinical efficacy of plasmapheresis in patients with neuromyelitis optica spectrum disorder and effects on circulating anti-aquaporin-4 antibody levels. J Clin Neurol. 2013 Jan;9(1):36-42. doi: 10.3988/jcn.2013.9.1.36. Epub 2013 Jan 3.

    PubMed 23346159

  • Wingerchuk DM, Banwell B, Bennett JL, Cabre P, Carroll W, Chitnis T, de Seze J, Fujihara K, Greenberg B, Jacob A, Jarius S, Lana-Peixoto M, Levy M, Simon JH, Tenembaum S, Traboulsee AL, Waters P, Wellik KE, Weinshenker BG; International Panel for NMO Diagnosis. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology. 2015 Jul 14;85(2):177-89. doi: 10.1212/WNL.0000000000001729. Epub 2015 Jun 19.

    PubMed 26092914

  • Araki M, Matsuoka T, Miyamoto K, Kusunoki S, Okamoto T, Murata M, Miyake S, Aranami T, Yamamura T. Efficacy of the anti-IL-6 receptor antibody tocilizumab in neuromyelitis optica: a pilot study. Neurology. 2014 Apr 15;82(15):1302-6. doi: 10.1212/WNL.0000000000000317. Epub 2014 Mar 14.

    PubMed 24634453

  • Yamasaki R, Matsushita T, Fukazawa T, Yokoyama K, Fujihara K, Ogino M, Yokota T, Miyamoto K, Niino M, Nomura K, Tomioka R, Tanaka M, Kawachi I, Ohashi T, Kaida K, Matsui M, Nakatsuji Y, Ochi H, Fukaura H, Kanda T, Nagaishi A, Togo K, Mizusawa H, Murai H, Kira J. Efficacy of intravenous methylprednisolone pulse therapy in patients with multiple sclerosis and neuromyelitis optica. Mult Scler. 2016 Sep;22(10):1337-48. doi: 10.1177/1352458515617248. Epub 2015 Nov 12.

    PubMed 26564994

  • Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O'Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol. 2005 Dec;58(6):840-6. doi: 10.1002/ana.20703.

    PubMed 16283615

  • van Winsen LM, Polman CH, Dijkstra CD, Tilders FJ, Uitdehaag BM. Suppressive effect of glucocorticoids on TNF-alpha production is associated with their clinical effect in multiple sclerosis. Mult Scler. 2010 Apr;16(4):500-2. doi: 10.1177/1352458509359721. Epub 2010 Jan 19.

    PubMed 20086025

  • Abboud H, Petrak A, Mealy M, Sasidharan S, Siddique L, Levy M. Treatment of acute relapses in neuromyelitis optica: Steroids alone versus steroids plus plasma exchange. Mult Scler. 2016 Feb;22(2):185-92. doi: 10.1177/1352458515581438. Epub 2015 Apr 28.

    PubMed 25921047

Questions about this trial

What is this clinical trial studying?

An observational study of Neuromyelitis Optica Spectrum Disorders, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04101058, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in