Trial record 7 of 23 for:    Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Nihon Pharmaceutical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01824251
First received: April 1, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks. [ Time Frame: 52weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • ISS [ Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks ] [ Designated as safety issue: No ]
  • maximum grip strength [ Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • the amplitude of the compound muscle action potential of the most severely affected motor nerve [ Time Frame: 1,4,28,52weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPB-01
Intravenous immunoglobulin
Drug: NPB-01
Other Name: Intravenous immunoglobulin

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824251

Locations
Japan
Nihon Pharmaceutical Co., Ltd Recruiting
Osaka, Japan
Contact: Yasumasa Ogawa       kaihatsu@nihon-pharm.co.jp   
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01824251     History of Changes
Other Study ID Numbers: NPB-01-09/C-01
Study First Received: April 1, 2013
Last Updated: July 10, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014