Trial record 1 of 9 for:    Multifocal Motor Neuropathy
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Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Nihon Pharmaceutical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01827072
First received: April 1, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Multifocal Motor Neuropathy
Drug: NPB-01
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.

Resource links provided by NLM:


Further study details as provided by Nihon Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Medical Research Council(MRC) score [ Time Frame: 49 weeks ] [ Designated as safety issue: No ]
  • maximum grip strength [ Time Frame: 49 weeks ] [ Designated as safety issue: No ]
  • The Guy's Neurological Disability Scale (GDNS) [ Time Frame: 49 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPB-01
Intravenous immunoglobulin
Drug: NPB-01
Other Name: immunoglobulin

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827072

Locations
Japan
Nihon Pharmaceutical Co., Ltd Recruiting
Osaka, Japan
Contact: Yasumasa Ogawa       kaihatsu@nihon-pharm.co.jp   
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01827072     History of Changes
Other Study ID Numbers: NPB-01-10/C-01
Study First Received: April 1, 2013
Last Updated: July 10, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nihon Pharmaceutical Co., Ltd:
IVIG in Multifocal Motor Neuropathy
Patients with Multifocal Motor Neuropathy

Additional relevant MeSH terms:
Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014