Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.

Study Overview
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Brief Summary
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Patients diagnosed with Multifocal Motor Neuropathy were confirmed based on the European Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Medical Research Council（MRC） score and the Guy's Neurological Disability Scale（GNDS） et al. As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by one year after the start of the study treatment.

Official Title
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NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.

Conditions
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Multifocal Motor Neuropathy

Intervention / Treatment
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* Drug: NPB-01


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients who need high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） therapy. 2. Patients who continued treatment for MMN without addition or increase at 30 days before informed consent. 3. Patients who MRC score increased 1 stage in greater than or equal to 2 muscles and not decreased relative other muscles to before at after in high-dose intravenous immunoglobulin therapy. 4. Patients with greater than or equal to twenty years old at informed consent. Exclusion Criteria: 1. Patients treated with Plasmapheresis at 3 months before informed consent. 2. Patients treated with Rituximab or Natalizumab at 6 months before informed consent. 3. Patients treated with Interferon-beta at 6 months before informed consent. 4. Patients treated with high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） at 8 weeks before informed consent. 5. Patients treated with intravenous immunoglobulin at 3 weeks before informed consent. 6. Patients with history of shock or hypersensitivity for NPB-01. 7. Patients with IgA deficiency. 8. Patients with malignancy. 9. Patients with impaired liver function. 10. Patients with impaired renal function. 11. Patients with cerebro- or cardiovascular disorders. 12. Patients with high risk of thromboembolism. 13. Patients with hemolytic/hemorrhagic anemia. 14. Patients with decreased cardiac function. 15. Patients with decreased platelet.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPB-01<br>Intravenous immunoglobulin | Drug: NPB-01<br> <br> * Other names: immunoglobulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Research Council（MRC） score |  | 49 weeks | 
| maximum grip strength |  | 49 weeks | 
| The Guy's Neurological Disability Scale (GDNS) |  | 49 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVIG in Multifocal Motor Neuropathy, Patients with Multifocal Motor Neuropathy