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NCT Number: NCT01824251

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

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.

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Key information

Conditions

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

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nihon Pharmaceutical Co., Ltd

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NPB-01

Drug

Other names: Intravenous immunoglobulin

Primary outcomes

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

    Time frame: 28weeks

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

    Time frame: 52weeks

Secondary outcomes

  1. INCAT score

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

  2. ISS

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

  3. maximum grip strength

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

  4. 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

  5. the amplitude of the compound muscle action potential of the most severely affected motor nerve

    Time frame: 1,4,28,52weeks

Sponsors and collaborators

Lead sponsor

Nihon Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2013
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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