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
Sponsored by
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
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
No
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
No
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
derived
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Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
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