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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2016
• Main ID: NCT01824251
• Date of registration: 01/04/2013
• Prospective Registration: Yes
• Primary sponsor: Nihon Pharmaceutical Co., Ltd
• Public title: Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
• Scientific title: NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
• Date of first enrolment: April 2013
• Target sample size: 49
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01824251
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 100 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyneuropathy

Intervention(s)

Drug: NPB-01

Primary Outcome(s)

proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks. [Time Frame: 52weeks]

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

Secondary Outcome(s)

the amplitude of the compound muscle action potential of the most severely affected motor nerve [Time Frame: 1,4,28,52weeks]

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

INCAT score [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]

Secondary ID(s)

NPB-01-09/C-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors