Trial record 1 of 14 for:    Multifocal Motor Neuropathy
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Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01827072
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Multifocal Motor Neuropathy Drug: NPB-01 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
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 : April 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: NPB-01
Intravenous immunoglobulin
Drug: NPB-01
Other Name: immunoglobulin

Primary Outcome Measures :
  1. Medical Research Council(MRC) score [ Time Frame: 49 weeks ]
  2. maximum grip strength [ Time Frame: 49 weeks ]
  3. The Guy's Neurological Disability Scale (GDNS) [ Time Frame: 49 weeks ]

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Senior)
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01827072

Nihon Pharmaceutical Co., Ltd
Osaka, Japan
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nihon Pharmaceutical Co., Ltd Identifier: NCT01827072     History of Changes
Other Study ID Numbers: NPB-01-10/C-01
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: October 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
Neuromuscular Diseases
Nervous System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs