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

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.

Timeline

Start

2013-04

Primary completion

2015-06

Completion

2015-06

Publications

• 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.

Drugs

Indications