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Completed

NCT Number: NCT01827072

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

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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Key information

Conditions

Multifocal Motor Neuropathy

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nihon Pharmaceutical Co., Ltd

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NPB-01

Drug

Other names: immunoglobulin

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nihon Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2013
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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