search
Back to results

Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.

Primary Purpose

Neuromyelitis Optica Spectrum Disorder

Status
Completed
Phase
Phase 2
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 Neuromyelitis Optica Spectrum Disorder focused on measuring IVIG in Neuromyelitis Optica spectrum disorder, Patients with Neuromyelitis Optica spectrum disorder

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients who become positive for anti-aquaporin 4 antibody or have becomed.
  2. Patients who have developed myelitis.
  3. Patients who run beyond greater than 30 days at least from last time in relapse.
  4. Patients who new neurological symptom or worsening neurological symptom or flared neurological symptom have sustained 24 hours at least not associated fever or infection.
  5. Patients who have an acute exacerbation at informed consent.
  6. Patients who need steroid plus therapy（1g/day for five consecutive days）.
  7. Patients who can start steroid plus therapy within 3 days after informed consent.
  8. Patients who be inadequate to effect to steroid plus therapy.
  9. Patients with greater than or equal to twenty years old at informed consent.

Exclusion Criteria:

  1. Patients who have developed optic neuritis.
  2. Patients treated with intravenous immunoglobulin within 14 days before informed consent.
  3. Patients with malignancy at informed consent.
  4. Patients with history of shock or hypersensitivity for NPB-01.
  5. Patients with IgA deficiency.
  6. Patients with impaired liver function.
  7. Patients with impaired renal function.
  8. Patients with cerebro- or cardiovascular disorders.
  9. Patients with high risk of thromboembolism.
  10. Patients with hemolytic/hemorrhagic anemia.
  11. Patients with decreased cardiac function.
  12. Patients with decreased platelet.

Sites / Locations

  • Japan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NPB-01

Arm Description

Intravenous immunoglobulin

Outcomes

Primary Outcome Measures

Change from Baseline Quantification of nerve and spinal cord impairment （QOSI） at 29 days
Change from Baseline Expanded Disability Status Scale （EDSS）/ Functional Systems （FS） at 29 days
Change from Baseline anti-aquaporin 4 antibody at 29 days

Secondary Outcome Measures

Full Information

First Posted
April 26, 2013
Last Updated
April 11, 2017
Sponsor
Nihon Pharmaceutical Co., Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT01845584
Brief Title
Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.
Official Title
NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (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 anti-aquaporin 4 antibody positive Neuromyelitis Optica spectrum disorder were confirmed based on diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive steroid plus therapy （1g/day for five consecutive days）. Subsequently, patients who not provided adequate effect of therapy to steroids plus therapy will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Patients evaluated Quantification of nerve and spinal cord impairment （QOSI） and the Expanded Disability Status Scale （EDSS）/ Functional Systems （FS） and anti-aquaporin 4 antibody 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
Neuromyelitis Optica Spectrum Disorder
Keywords
IVIG in Neuromyelitis Optica spectrum disorder, Patients with Neuromyelitis Optica spectrum disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (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
Change from Baseline Quantification of nerve and spinal cord impairment （QOSI） at 29 days
Time Frame
29 days
Title
Change from Baseline Expanded Disability Status Scale （EDSS）/ Functional Systems （FS） at 29 days
Time Frame
29 days
Title
Change from Baseline anti-aquaporin 4 antibody at 29 days
Time Frame
29 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who become positive for anti-aquaporin 4 antibody or have becomed. Patients who have developed myelitis. Patients who run beyond greater than 30 days at least from last time in relapse. Patients who new neurological symptom or worsening neurological symptom or flared neurological symptom have sustained 24 hours at least not associated fever or infection. Patients who have an acute exacerbation at informed consent. Patients who need steroid plus therapy（1g/day for five consecutive days）. Patients who can start steroid plus therapy within 3 days after informed consent. Patients who be inadequate to effect to steroid plus therapy. Patients with greater than or equal to twenty years old at informed consent. Exclusion Criteria: Patients who have developed optic neuritis. Patients treated with intravenous immunoglobulin within 14 days before informed consent. Patients with malignancy at informed consent. Patients with history of shock or hypersensitivity for NPB-01. 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
Japan
City
Osaka,
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.

We'll reach out to this number within 24 hrs