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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01827072

Enrollment

Registered

2013-04-09

Start date

2013-04-30

Completion date

2015-06-30

Last updated

2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multifocal Motor Neuropathy

Keywords

IVIG in Multifocal Motor Neuropathy, Patients with Multifocal Motor Neuropathy

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.

Interventions

DRUGNPB-01

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 100 Years

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.

Design outcomes

Primary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026