NCT01827072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

October 1, 2014

Enrollment Period

2.2 years

First QC Date

April 1, 2013

Last Update Submit

January 17, 2016

Conditions

Multifocal Motor Neuropathy

Keywords

IVIG in Multifocal Motor NeuropathyPatients with Multifocal Motor Neuropathy

Outcome Measures

Primary Outcomes (3)

  • Medical Research Council（MRC） score

    49 weeks

  • maximum grip strength

    49 weeks

  • The Guy's Neurological Disability Scale (GDNS)

    49 weeks

Study Arms (1)

NPB-01

EXPERIMENTAL

Intravenous immunoglobulin

Drug: NPB-01

Interventions

NPB-01DRUG
Also known as: immunoglobulin
NPB-01

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients who need high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） therapy.
  • \. Patients who continued treatment for MMN without addition or increase at 30 days before informed consent.
  • \. 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.
  • \. Patients with greater than or equal to twenty years old at informed consent.

You may not qualify if:

  • \. Patients treated with Plasmapheresis at 3 months before informed consent.
  • \. Patients treated with Rituximab or Natalizumab at 6 months before informed consent.
  • \. Patients treated with Interferon-beta at 6 months before informed consent.
  • \. Patients treated with high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） at 8 weeks before informed consent.
  • \. Patients treated with intravenous immunoglobulin at 3 weeks before informed consent.
  • \. Patients with history of shock or hypersensitivity for NPB-01.
  • \. Patients with IgA deficiency.
  • \. Patients with malignancy.
  • \. Patients with impaired liver function.
  • \. Patients with impaired renal function.
  • \. Patients with cerebro- or cardiovascular disorders.
  • \. Patients with high risk of thromboembolism.
  • \. Patients with hemolytic/hemorrhagic anemia.
  • \. Patients with decreased cardiac function.
  • \. Patients with decreased platelet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nihon Pharmaceutical Co., Ltd

Osaka, Japan

Location

Related Publications (1)

  • 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.

    PMID: 29635876DERIVED

MeSH Terms

Interventions

Immunoglobulins

Intervention Hierarchy (Ancestors)

ImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 9, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 20, 2016

Record last verified: 2014-10

Locations

JP(1)