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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nihon Pharmaceutical Co., Ltd
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

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.