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

Phase 3

Completed

• Conditions: Multifocal Motor Neuropathy
• Interventions: Drug: NPB-01

• Registration Number: NCT01827072
• Lead Sponsor: Nihon Pharmaceutical Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-09
• Status Verified: 2014-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2016-01-17
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NPB-01	NPB-01	Intravenous immunoglobulin

Primary Outcome Measures

Name	Time	Method
maximum grip strength	49 weeks
Medical Research Council（MRC） score	49 weeks
The Guy's Neurological Disability Scale (GDNS)	49 weeks

Trial Locations

Locations (1)

Nihon Pharmaceutical Co., Ltd; 🇯🇵 Osaka, Japan