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

Multifocal Motor Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827072
• Other study ID #: NPB-01-10/C-01
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2013
• Last updated: January 17, 2016
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2014
• Source: Nihon Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 100 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multifocal Motor Neuropathy
• Neuritis

Intervention

Drug:
• NPB-01

Locations

Country	Name	City	State
Japan	Nihon Pharmaceutical Co., Ltd	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Research Council(MRC) score		49 weeks	No
Primary	maximum grip strength		49 weeks	No
Primary	The Guy's Neurological Disability Scale (GDNS)		49 weeks	No