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A Double Blind Trial To Evaluate The Safety And Efficacy Of Eculizumab In Relapsing NMO Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Alexion Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01892345
First received: June 20, 2013
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

The primary objective of the study is to assess the efficacy and safety of eculizumab treatment as compared to placebo in relapsing NMO patients using a time to first relapse study design.


Condition Intervention Phase
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Drug: Eculizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • Time to first relapse [ Time Frame: from baseline to end of study ] [ Designated as safety issue: No ]
    On-trial NMO Relapse, as defined by the protocol.


Secondary Outcome Measures:
  • Overall safety and tolerability of eculizumab [ Time Frame: from baseline to end of study ] [ Designated as safety issue: Yes ]
    Adverse events, vital signs and laboratory assessments


Estimated Enrollment: 132
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo contains the same buffer components without the active ingredient
Experimental: Eculizumab

Induction Phase: 900 mg IV weekly X 4

Maintenance Phase: 1200 mg IV every 2 weeks 6-104

Drug: Eculizumab

Induction Phase: 900 mg IV weekly X 4 Maintenance Phase: 1200 mg IV every two weeks 6-104

Drug: Placebo Other Names: Placebo


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male or female patients ≥ 18 years old
  2. Diagnosis of NMO or NMO spectrum disorder
  3. All patients must be NMO-IgG seropositive
  4. Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months (with at least 1 relapse in the 12 months prior to the Screening)
  5. EDSS score ≤7
  6. Immunosuppressive therapy is allowed provided patients have been on a stable maintenance dose prior to the Screening and remain on a stable dose for the duration of the study

Key Exclusion Criteria:

  1. Use of rituximab within 3 months prior to screening
  2. Use of mitoxantrone within 3 months prior to screening
  3. Use of IVIg within 3 weeks prior to screening
  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: NCT01892345

Contacts
Contact: Alexion Pharmaceuticals (Sponsor) clinicaltrials@alxn.com

  Show 57 Study Locations
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

Publications:
Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01892345     History of Changes
Other Study ID Numbers: ECU-NMO-301
Study First Received: June 20, 2013
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexion Pharmaceuticals:
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Devic's disease, Transverse Myelitis
Optic Neuritis
relapse
eculizumab
soliris
NMO-IgG
CNS Autoimmune Disorders
Demyelinating Disorders

Additional relevant MeSH terms:
Neuromyelitis Optica
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Cranial Nerve Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Eye Diseases
Immune System Diseases
Multiple Sclerosis
Myelitis, Transverse
Nervous System Diseases
Optic Nerve Diseases
Optic Neuritis

ClinicalTrials.gov processed this record on November 20, 2014