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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

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.

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Detailed Description

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Conditions

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Multifocal Motor Neuropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NPB-01

Intravenous immunoglobulin

Group Type EXPERIMENTAL

NPB-01

Intervention Type DRUG

Interventions

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NPB-01

Intervention Type DRUG

Other Intervention Names

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immunoglobulin

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No