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

Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824251
• Other study ID #: NPB-01-09/C-01
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2013
• Last updated: January 17, 2016
• Start date: April 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2014
• Source: Nihon Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 100 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyneuropathy
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Drug:
• NPB-01

Locations

Country	Name	City	State
Japan	Nihon Pharmaceutical Co., Ltd	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks.		28weeks	No
Primary	proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks.		52weeks	No
Secondary	INCAT score		1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks	No
Secondary	ISS		1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks	No
Secondary	maximum grip strength		1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks	No
Secondary	Medical Research Council(MRC) sum score		1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks	No
Secondary	the amplitude of the compound muscle action potential of the most severely affected motor nerve		1,4,28,52weeks	No