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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Contacts
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)
maximum grip strength [Time Frame: 49 weeks]
Medical Research Council(MRC) score [Time Frame: 49 weeks]
The Guy's Neurological Disability Scale (GDNS) [Time Frame: 49 weeks]
Secondary Outcome(s)
Secondary ID(s)
NPB-01-10/C-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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