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.

April 11, 2017 updated by: Nihon Pharmaceutical Co., Ltd

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka,, Japan
        • Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NPB-01
Intravenous immunoglobulin
Drug: NPB-01
Other Names:
  • Intravenous immunoglobulin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nihon Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPB-01-08/E-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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