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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Nihon Pharmaceutical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01845584
First received: April 26, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Neuromyelitis Optica Spectrum Disorder
Drug: NPB-01
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Nihon Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Change from Baseline Quantification of nerve and spinal cord impairment (QOSI) at 29 days [ Time Frame: 29 days ] [ Designated as safety issue: No ]
  • Change from Baseline Expanded Disability Status Scale (EDSS)/ Functional Systems (FS) at 29 days [ Time Frame: 29 days ] [ Designated as safety issue: No ]
  • Change from Baseline anti-aquaporin 4 antibody at 29 days [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 7
Study Start Date: May 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPB-01
Intravenous immunoglobulin
Drug: NPB-01
Other Name: Intravenous immunoglobulin

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845584

Locations
Japan
Japan Recruiting
Osaka,, Japan
Contact: Yasumasa Ogawa       kaihatsu@nihon-pharm.co.jp   
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01845584     History of Changes
Other Study ID Numbers: NPB-01-08/E-01
Study First Received: April 26, 2013
Last Updated: July 10, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nihon Pharmaceutical Co., Ltd:
IVIG in Neuromyelitis Optica spectrum disorder
Patients with Neuromyelitis Optica spectrum disorder

Additional relevant MeSH terms:
Myelitis, Transverse
Disease
Neuromyelitis Optica
Pathologic Processes
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014