Status:
COMPLETED
Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Multifocal Motor Neuropathy
Eligibility:
All Genders
20-100 years
Phase:
PHASE3
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 crit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01827072
Start Date
April 1 2013
End Date
June 1 2015
Last Update
January 20 2016
Active Locations (1)
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1
Nihon Pharmaceutical Co., Ltd
Osaka, Japan