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

Primary Purpose

Multifocal Motor Neuropathy

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
NPB-01
Sponsored by
Nihon Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multifocal Motor Neuropathy focused on measuring IVIG in Multifocal Motor Neuropathy, Patients with Multifocal Motor Neuropathy

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nihon Pharmaceutical Co., Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NPB-01

Arm Description

Intravenous immunoglobulin

Outcomes

Primary Outcome Measures

Medical Research Council（MRC） score
maximum grip strength
The Guy's Neurological Disability Scale (GDNS)

Secondary Outcome Measures

Full Information

First Posted
April 1, 2013
Last Updated
January 17, 2016
Sponsor
Nihon Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01827072
Brief Title
Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.
Official Title
NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nihon Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multifocal Motor Neuropathy
Keywords
IVIG in Multifocal Motor Neuropathy, Patients with Multifocal Motor Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NPB-01
Arm Type
Experimental
Arm Description
Intravenous immunoglobulin
Intervention Type
Drug
Intervention Name(s)
NPB-01
Other Intervention Name(s)
immunoglobulin
Primary Outcome Measure Information:
Title
Medical Research Council（MRC） score
Time Frame
49 weeks
Title
maximum grip strength
Time Frame
49 weeks
Title
The Guy's Neurological Disability Scale (GDNS)
Time Frame
49 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Nihon Pharmaceutical Co., Ltd
City
Osaka
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29635876
Citation
Kuwabara S, Misawa S, Mori M, Iwai Y, Ochi K, Suzuki H, Nodera H, Tamaoka A, Iijima M, Toda T, Yoshikawa H, Kanda T, Sakamoto K, Kusunoki S, Sobue G, Kaji R; Glovenin-I MMN Study Group. Intravenous immunoglobulin for maintenance treatment of multifocal motor neuropathy: A multi-center, open-label, 52-week phase 3 trial. J Peripher Nerv Syst. 2018 Jun;23(2):115-119. doi: 10.1111/jns.12268. Epub 2018 Apr 24.
Results Reference
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Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.

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