CompletedPhase 3

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

Japan13 participantsStarted 2013-04

Plain-language 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.

Who can participate

Age range

20 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Medical Research Council（MRC） score

Timeframe: 49 weeks

maximum grip strength

Timeframe: 49 weeks

The Guy's Neurological Disability Scale (GDNS)

Timeframe: 49 weeks

Trial details

NCT IDNCT01827072

SponsorNihon Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More Multifocal Motor Neuropathy trials

Plain-language summary

Who can participate

Age range

20 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.