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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2016
• Main ID: NCT01827072
• Date of registration: 01/04/2013
• Prospective Registration: Yes
• Primary sponsor: Nihon Pharmaceutical Co., Ltd
• Public title: Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.
• Scientific title: NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.
• Date of first enrolment: April 2013
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01827072
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 100 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multifocal Motor Neuropathy

Intervention(s)

Drug: NPB-01

Primary Outcome(s)

Medical Research Council(MRC) score [Time Frame: 49 weeks]

maximum grip strength [Time Frame: 49 weeks]

The Guy's Neurological Disability Scale (GDNS) [Time Frame: 49 weeks]

Secondary ID(s)

NPB-01-10/C-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors