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

Nihon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Multifocal Motor Neuropathy

Treatments: Drug: NPB-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT01827072

NPB-01-10/C-01

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

NPB-01

Experimental group

Description:

Intravenous immunoglobulin

Treatment:

Drug: NPB-01