multifocal motor neuropathy,MMN
Conditions
Interventions
Intervention group:Intravenous immunoglobulin (IVIg)
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Must sign written informed consent before conducting any study-related activities, and must be able to understand the integrity nature and purpose of the study, including possible risks and adverse effects; 2. Adult males and females aged 18-75 years (inclusive) at screening; 3. Body weight range of 40-120 kg at screening, diagnosed with confirmed MMN or likely MMN according to the European Union of Neurological Societies (EFNS)/Peripheral Neurological Society (PNS) (EFNS/PNS) 2010 guideline 16 at screening; 4. Diagnosed with confirmed MMN or likely MMN according to the European Union of Neurological Societies (EFNS)/Peripheral Neurology Society (PNS) (EFNS/PNS) 2010 guideline 16 at screening; 5. No clinically significant abnormalities (as judged by the investigator), including: no clinically significant results of previous serum biochemistry, hematology, coagulation function, urinalysis routine tests or ECG; 6. Willing and able to complete all study assessments as required and comply with protocol schedules and restrictions.
Exclusion criteria
Exclusion criteria: 1. History of or current presence of significant medical/surgical disease, including any acute illness or major surgery that is judged by the investigator to be clinically significant or may have a potential impact on safety/efficacy or study procedures; 2. Any comorbidities that may interfere with outcome evaluation, such as severe diabetic neuropathy, chronic inflammatory demyelinating polyneuropathy, inflammatory arthritis or osteoarthritis involving the hand, etc.; 3. Concomitant or previous use of targeted B-cell drugs such as rituximab. If the patient has used this class of drugs in the past, the drug will be discontinued for at least 6 months at the time of enrollment initiation of treatment and will not be used for the entire duration of the study; 4. Concomitant use of cyclophosphamide, mycophenolate mofetil, azathioprine, cyclosporine, corticosteroid hormones or other immunosuppressants. If the patient has previously used the above drugs, discontinue at least one day before enrollment to start treatment and no longer use them throughout the study; 5. Concomitant or previous use of complement inhibitors, including in clinical research settings; 6. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody test results in the past history. Patients with no evidence of cirrhosis, who have completed a radical treatment regimen for HCV and are identified by a gastroenterologist as having no active HCV will not be excluded; 7. Known diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as parents, siblings, or children); 8. History of active malignant tumor within 5 years prior to screening, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has been curatively resected, carcinoma in situ of the cervix that has been curatively treated, or low-grade adenocarcinoma of the prostate that only needs to be observed; 9. Drug or alcohol abuse judged by the investigator to be clinically significant; 10. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational drug (whichever is longer) before Day 1; 11. Has any other overlapping disease that may affect the study assessment or outcome of the disease itself or disease treatment; 12. Presence of any other condition (including psychiatric illness or previous treatment) that would make the patient unsuitable for participation in this study as judged by the investigator, including inability to adequately cooperate with the requirements of the study protocol or possible non-compliance with certain study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average grip strength after treatment for 12 to 24 weeks, changes compared to baseline and percentage change; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean and change from baseline in the Medical Research Council total score (MRC-14) after 12 weeks to 24 weeks of treatment;Mean and change from baseline in Rasch-Built Multifocal Motor Neuropathy Global Disability Scale (MMN-RODS) score after 12 to 24 weeks of treatment;Mean change from baseline in the corrected Inflammatory Neuropathy Causes and Treatment Scale (INCAT) disability score after 12 to 24 weeks of treatment;Change in VAS score from baseline after treatment for 12 to 24 weeks.;Change in ANA titer after treatment for 12 to 24 weeks compared to baseline; | — |
Countries
China
Contacts
Public ContactHai Chen
Xuanwu Hospital Capital Medical University
Outcome results
None listed