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

NCT01824251 | Completed Phase 3

• 1 other identifier: NPB-01-09/C-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

IVIG in Chronic Inflammatory Demyelinating Polyneuropathy; Patients with Chronic Inflammatory Demyelinating Polyneuropathy

Outcome Measures

Primary Outcomes (2)

• proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks.

  28weeks

• proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks.

  52weeks

Secondary Outcomes (5)

• INCAT score

  1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks

• ISS

  1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks

• maximum grip strength

  1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks

• Medical Research Council（MRC） sum score

  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

  1,4,28,52weeks

Study Arms (1)

NPB-01

EXPERIMENTAL

Intravenous immunoglobulin

Drug: NPB-01

Interventions

NPB-01 DRUG

Also known as: Intravenous immunoglobulin

NPB-01

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Patients with evidence of myelopathy or demyelination of central nerve
• \. 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）
• \. 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.
• \. Patients with multifocal motor neuropathy.
• \. Patients treated with plasmapheresis at 3 months before informed consent.
• \. Patients treated with rituximab 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 at informed consent.
• \. Patients with impaired liver function.
• \. Patients with impaired renal function.
• \. Patients with cerebro- or cardiovascular disorders.
• \. Patients with high risk of thromboembolism.

Sponsors & Collaborators

• Nihon Pharmaceutical Co., Ltd: lead

Study Sites (1)

Nihon Pharmaceutical Co., Ltd

Osaka, Japan

Location

Related Publications (1)

• Kuwabara S, Mori M, Misawa S, Suzuki M, Nishiyama K, Mutoh T, Doi S, Kokubun N, Kamijo M, Yoshikawa H, Abe K, Nishida Y, Okada K, Sekiguchi K, Sakamoto K, Kusunoki S, Sobue G, Kaji R; Glovenin-I CIDP Study Group. Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy: a multicentre, open-label, 52-week phase III trial. J Neurol Neurosurg Psychiatry. 2017 Oct;88(10):832-838. doi: 10.1136/jnnp-2017-316427. Epub 2017 Aug 2.

  PMID: 28768822 DERIVED

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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 4, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2014-10

Locations

JP (1)