Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)

April 16, 2015 updated by: Novartis Pharmaceuticals

A 48-week, Double-blind, Randomized, Multi-center, Parallel-group Study Comparing Structural Changes in the Retina and Evolution of Visual Function After Immediate Versus Delayed Treatment With Fingolimod in Patients With Acute Demyelinating Optic Neuritis

To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

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

  • Spain
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Novartis Investigative Site
  • United States
    • Florida
      • St. Petersburg, Florida, United States, 33713
        • Novartis Investigative Site

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical signs and symptoms of ADON in one eye (loss of vision, pain on movement, impairment of color vision)
  • First episode of ADON
  • Able to undergo treatment with IV steroids

Exclusion Criteria:

  • History of any unexplained eye or neurological symptoms lasting longer than 48 hours
  • Optic neuritis in both eyes
  • Concomitant condition in either eye, other than optic neuritis
  • History of heart condition/disease
  • Patients with uncontrolled diabetes mellitus
  • Patients with liver conditions/disease
  • Inability to undergo MRI
  • Pregnant or nursing women

  • Women of childbearing potential who are not using highly effective method of birth control

    • Other protocol-defined inclusion/exclusion criteria may apply

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fingolimod 0.5mg/daily
Oral capsule dose was given once daily for 48 weeks
Drug: Fingolimod 0.5mg/daily
Other Names:
  • FTY, Gilenya
Placebo Comparator: Placebo
Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo
Time Frame: Baseline and Week 18
Due to early termination and low patient enrollment the primary outcome measure was not analyzed
Baseline and Week 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low Contrast Visual Acuity (LCVA)
Time Frame: Baseline, Week 48
Due to early termination and low patient enrollment this trial was not powered for efficacy
Baseline, Week 48
Vision Based Quality of Life (QoL) Utility Score
Time Frame: Baseline, Week 18, Week 48
Due to early termination and low patient enrollment this trial was not powered for efficacy
Baseline, Week 18, Week 48
Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS
Time Frame: Baseline, Week 18, Week 48
Due to early termination and low patient enrollment this trial was not powered for efficacy
Baseline, Week 18, Week 48
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60
Number of particpants with Adverse events as a measure of safety and tolerability
Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

August 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

December 21, 2012

First Posted (Estimate)

December 31, 2012

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720D2402
  • 2012-002968-27 (EudraCT Number)

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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