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Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome

Primary Purpose

Guillain-Barré Syndrome

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
NPB-01
Sponsored by
Nihon Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Guillain-Barré Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. In principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms.
  2. Patients with predominant motor neuropathy and Hughes's Functional Grade(FG) is grade4 or grade5(in this regard, if symptoms is progressive, patients with FG is grade3 involve in this study).
  3. Patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset.
  4. Patients with greater than or equal to 18 years old at informed consent.

Exclusion Criteria:

  1. Patients with history of shock for NPB-01.
  2. Patients with history of hypersensitivity for NPB-01.
  3. Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis, botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone, organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to HIV,impaired peripheral neuropathy except Guillain-Barré syndrome.
  4. Patients with malignancy at informed consent.
  5. Patients treated with immune globulin at 8 weeks before informed consent.
  6. Patients with IgA deficiency.
  7. Patients with impaired liver function.
  8. Patients with impaired renal function.
  9. Patients with cerebro- or cardiovascular disorders.
  10. Patients with high risk of thromboembolism.
  11. Patients with hemolytic/hemorrhagic anemia.
  12. Patients with decreased cardiac function.
  13. 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

Outcomes

Primary Outcome Measures

proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.

Secondary Outcome Measures

days required for 1 grade improvement of the Hughes functional grading scale(FG)
days required for 2 grade improvement of the Hughes functional grading scale(FG)
changes in Hughes functional grading scale(FG)
proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.
days required for 1 grade improvement of the Arm Grade(AG)
days required for 2 grade improvement of the Arm Grade(AG)
changes in Arm Grade(AG)
changes in manual muscle testing(MMT)
changes in grip strength
changes in activity of daily living(ADL)
changes in electrophysiological findings

Full Information

First Posted
August 12, 2014
Last Updated
April 11, 2017
Sponsor
Nihon Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02221271
Brief Title
Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 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 Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. 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. Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al. As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 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
Guillain-Barré Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NPB-01
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NPB-01
Primary Outcome Measure Information:
Title
proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.
Time Frame
Baseline,4weeks
Secondary Outcome Measure Information:
Title
days required for 1 grade improvement of the Hughes functional grading scale(FG)
Time Frame
Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Title
days required for 2 grade improvement of the Hughes functional grading scale(FG)
Time Frame
Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Title
changes in Hughes functional grading scale(FG)
Time Frame
Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Title
proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.
Time Frame
Baseline,4weeks
Title
days required for 1 grade improvement of the Arm Grade(AG)
Time Frame
Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Title
days required for 2 grade improvement of the Arm Grade(AG)
Time Frame
Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Title
changes in Arm Grade(AG)
Time Frame
Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Title
changes in manual muscle testing(MMT)
Time Frame
Baseline,1,2,3,4,8,12 weeks
Title
changes in grip strength
Time Frame
Baseline,1,2,3,4,8,12 weeks
Title
changes in activity of daily living(ADL)
Time Frame
Baseline,1,2,3,4,8,12 weeks
Title
changes in electrophysiological findings
Time Frame
Baseline,4,12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms. Patients with predominant motor neuropathy and Hughes's Functional Grade(FG) is grade4 or grade5(in this regard, if symptoms is progressive, patients with FG is grade3 involve in this study). Patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset. Patients with greater than or equal to 18 years old at informed consent. Exclusion Criteria: Patients with history of shock for NPB-01. Patients with history of hypersensitivity for NPB-01. Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis, botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone, organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to HIV,impaired peripheral neuropathy except Guillain-Barré syndrome. Patients with malignancy at informed consent. Patients treated with immune globulin at 8 weeks before informed consent. Patients with IgA deficiency. Patients with impaired liver function. Patients with impaired renal function. Patients with cerebro- or cardiovascular disorders. Patients with high risk of thromboembolism. Patients with hemolytic/hemorrhagic anemia. Patients with decreased cardiac function. Patients with decreased platelet.
Facility Information:
Facility Name
Nihon Pharmaceutical Co., Ltd
City
Osaka
Country
Japan

12. IPD Sharing Statement

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Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome

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