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

This study has been completed.
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd Identifier:
First received: April 1, 2013
Last updated: January 17, 2016
Last verified: October 2014

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.

Condition Intervention Phase
Chronic Inflammatory Demyelinating Polyneuropathy Drug: NPB-01 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

Resource links provided by NLM:

Further study details as provided by Nihon Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 49
Study Start Date: April 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPB-01
Intravenous immunoglobulin
Drug: NPB-01
Other Name: Intravenous immunoglobulin


Ages Eligible for Study:   20 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1. Patients with progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy within 2 months prior to the date informed consent is obtained.
  • 2. Patients who INCAT score between 2-9. (If the INCAT score is 1 in upper limb, the INCAT score of 2 must be exclusively from leg disability to qualify.)
  • 3. Patients who need high-dose intravenous immunoglobulin therapy.
  • 4. Patients who continued treatment for CIDP without addition or increase at 30 days before informed consent.
  • 5. Patients with greater than or equal to twenty years old at informed consent.

Exclusion Criteria:

  • 1. Patients with evidence of myelopathy or demyelination of central nerve
  • 2. Patients with evidence of stroke, central nerve system trauma, or persistent neurological deficits due to peripheral neuropathy from other causes(diabetic neuropathy, IgM paraproteinaemia, uraemic neuropathy, toxic neuropathy, hereditary neuropathy)
  • 3. Patients with evidence of neuropathy or alcoholic neuropathy or vitamin deficiency neuropathy due to myeloma, lymphoma, sarcoidosis, systemic lupus erythematosus, malignancy, vasculitis, Crow‐Fukase syndrome, Sjögren syndrome.
  • 4. Patients with multifocal motor neuropathy.
  • 5. Patients treated with plasmapheresis at 3 months before informed consent.
  • 6. Patients treated with rituximab at 6 months before informed consent.
  • 7. Patients treated with high-dose intravenous immunoglobulin(greater than or equal to 1g/kg) at 8 weeks before informed consent.
  • 8. Patients treated with intravenous immunoglobulin at 3 weeks before informed consent.
  • 9. Patients with history of shock or hypersensitivity for NPB-01.
  • 10. Patients with IgA deficiency.
  • 11. Patients with malignancy at informed consent.
  • 12. Patients with impaired liver function.
  • 13. Patients with impaired renal function.
  • 14. Patients with cerebro- or cardiovascular disorders.
  • 15. Patients with high risk of thromboembolism.
  • 16. Patients with hemolytic/hemorrhagic anemia.
  • 17. Patients with decreased cardiac function.
  • 18. Patients with decreased platelet.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01824251

Nihon Pharmaceutical Co., Ltd
Osaka, Japan
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
  More Information

Responsible Party: Nihon Pharmaceutical Co., Ltd Identifier: NCT01824251     History of Changes
Other Study ID Numbers: NPB-01-09/C-01
Study First Received: April 1, 2013
Last Updated: January 17, 2016

Keywords provided by Nihon Pharmaceutical Co., Ltd:
IVIG in Chronic Inflammatory Demyelinating Polyneuropathy
Patients with Chronic Inflammatory Demyelinating Polyneuropathy

Additional relevant MeSH terms:
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on September 25, 2017