Trial record 1 of 8 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.
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
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
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014