Status unknownPhase 4NMOSDNCT02809079

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Mycophenolate mofetil

    Inosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor

  • Prednisone

    Glucocorticoid receptor agonist

What it measured

Main measures

  • Annualized relapse rate day 360

    day 360 after staring treatment

    Relapses

Other measures (5)

  • expanded disability status scale

    day 1, 14, 30, 90, 180, 270, 360 after staring treatment

    Disability progression
  • Hauser scale

    day 1, 14, 30, 90, 180, 270, 360 after staring treatment

  • vision scale

    day 1, 14, 30, 90, 180, 270, 360 after staring treatment

    Vision
  • Lesions in brain and spinal cord

    day 1, 14, 30, 90, 180, 270, 360 after staring treatment

    MRI lesions
  • Annualized relapse rate

    day 1, 14, 30, 90, 180, 270 after staring treatment

    Relapses

Who could take part

NMOSD · 18 to 65

Inclusion Criteria: * Meet the 2006 Wingerchuk diagnostic criteria; * NMO-immunoglobulin G seropositive; * Between 18 to 65 years old; * Relapse: more than 2 relapses in recent 2 years; more than 1 relapses in recent 1 years; * Expanded disability status scale: expanded disability status scale≤7.0, and visual acuity ≥20 / 100 at least in one eye * Understand the purpose and procedures of this study, and written informed consent is obtained. Exclusion Criteria: * Using immunosuppressive agents and other drugs affect evaluation, and drug withdrawal less than 3 months; * Patients with any of the following diseases: transaminases elevation exceed 2 times of the normal upper limit; white blood cell \<4 × 109 / L, Hemoglobin \<80g / L, platelet \<100 × 109 / L; * With serious cardiovascular, liver, kidneys and other vital organs and blood, endocrine system diseases, cancer history; * With immunodeficiency, uncontrolled infection and active gastrointestinal diseases (such as gastric ulcer, etc.); * Pregnancy, breast-feeding women and male or female who plans to conceive recently; * Allergy to mycophenolate mofetil and prednisone.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Neuromyelitis optica (NMO) is an autoimmune inflammatory demyelinating disease of the central nervous system that leads to blindness and paralysis. Since disability accrues incrementally related to attacks, attack prevention with immunosuppressive therapy is the mainstay of preventing disability. However, there is no standard immunosuppressive treatment strategy for NMO relapse prevention. In a previous study, the investigators provided evidence supporting the use of azathioprine plus a low dose corticosteroid as an effective strategy which is associated with a reduction in the risk of relapse in Chinese patients with NMO, but azathioprine has bone marrow suppression and other side effects. Mycophenolate mofetil (MMF) is a new immunosuppressant with rapid onset, fewer side effects and other advantages. In recent years, MMF has been used in different immune-related neurological diseases; some literature shown the possible efficacy of MMF in NMO treatment. In this research, a multi-center (Third Affiliated Hospital of Sun Yat-sen University, Zhongshan Ophthalmic Centre of Sun Yat-sen University, Nangfang Hospital of Southern Medical University) study will carry out to evaluate the efficacy and safety of mycophenolate mofetil therapy in NMO spectrum disorders.

Papers

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Related trials

History

    1. Started

      Jan 2016

    2. Main results due

      Dec 2017

    3. Finished

      Dec 2017

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