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

Primary Purpose

Chronic Inflammatory Demyelinating Polyneuropathy

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

NPB-01

About this trial

This is an interventional treatment trial for Chronic Inflammatory Demyelinating Polyneuropathy focused on measuring IVIG in Chronic Inflammatory Demyelinating Polyneuropathy, Patients with Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Nihon Pharmaceutical Co., Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NPB-01

Arm Description

Intravenous immunoglobulin

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

INCAT score

ISS

maximum grip strength

Medical Research Council（MRC） sum score

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

Full Information

NCT ID

NCT01824251

First Posted

April 1, 2013

Last Updated

January 17, 2016

Sponsor

Nihon Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01824251

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nihon Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NPB-01

Arm Type

Experimental

Arm Description

Intravenous immunoglobulin

Intervention Type

Drug

Intervention Name(s)

NPB-01

Other Intervention Name(s)

Intravenous immunoglobulin

Primary Outcome Measure Information:

Title

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

Time Frame

28weeks

Title

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

Time Frame

52weeks

Secondary Outcome Measure Information:

Title

INCAT score

Time Frame

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

Title

ISS

Time Frame

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

Title

maximum grip strength

Time Frame

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

Title

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

Title

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

Time Frame

1,4,28,52weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Nihon Pharmaceutical Co., Ltd

City

Osaka

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

28768822

Citation

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.

Results Reference

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

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