Clinical Trial: Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

Brief Summary:

Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy 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 Inflammatory Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） 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.


Detailed Summary:
Sponsor: Nihon Pharmaceutical Co., Ltd

Current Primary Outcome:

  • proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks. [ Time Frame: 28weeks ]
  • proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks. [ Time Frame: 52weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • INCAT score [ Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks ]
  • ISS [ Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks ]
  • maximum grip strength [ Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks ]
  • Medical Research Council（MRC） sum score [ Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks ]
  • the amplitude of the compound muscle action potential of the most severely affected motor nerve [ Time Frame: 1,4,28,52weeks ]


Original Secondary Outcome: Same as current

Information By: Nihon Pharmaceutical Co., Ltd

Dates:
Date Received: April 1, 2013
Date Started: April 2013
Date Completion:
Last Updated: January 17, 2016
Last Verified: October 2014