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

Sponsor
Nihon Pharmaceutical Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT01827072
Collaborator
(none)
13
Enrollment
1
Location
1
Arm
26
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: NPB-01

Intravenous immunoglobulin

Drug: NPB-01
Other Names:
  • immunoglobulin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Medical Research Council（MRC） score [49 weeks]

    2. maximum grip strength [49 weeks]

    3. The Guy's Neurological Disability Scale (GDNS) [49 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Patients who need high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） therapy.
      1. Patients who continued treatment for MMN without addition or increase at 30 days before informed consent.
      1. 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.
      1. 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.
      1. Patients treated with Rituximab or Natalizumab at 6 months before informed consent.
      1. Patients treated with Interferon-beta at 6 months before informed consent.
      1. Patients treated with high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） at 8 weeks before informed consent.
      1. Patients treated with intravenous immunoglobulin at 3 weeks before informed consent.
      1. Patients with history of shock or hypersensitivity for NPB-01.
      1. Patients with IgA deficiency.
      1. Patients with malignancy.
      1. Patients with impaired liver function.
      1. Patients with impaired renal function.
      1. Patients with cerebro- or cardiovascular disorders.
      1. Patients with high risk of thromboembolism.
      1. Patients with hemolytic/hemorrhagic anemia.
      1. Patients with decreased cardiac function.
      1. Patients with decreased platelet.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nihon Pharmaceutical Co., Ltd Osaka Japan

    Sponsors and Collaborators

    • Nihon Pharmaceutical Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nihon Pharmaceutical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT01827072
    Other Study ID Numbers:
    • NPB-01-10/C-01
    First Posted:
    Apr 9, 2013
    Last Update Posted:
    Jan 20, 2016
    Last Verified:
    Oct 1, 2014
    Keywords provided by Nihon Pharmaceutical Co., Ltd
    IVIG in Multifocal Motor Neuropathy
    Patients with Multifocal Motor Neuropathy
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases
    Neuritis
    Immunoglobulins

    Study Results

    No Results Posted as of Jan 20, 2016