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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01757691
Recruitment Status : Terminated (Discontinuation of this study was based on Novartis decision to discontinue development of fingolimod for the treatment of ADON)
First Posted : December 31, 2012
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Acute Demylelinating Optic Neuritis Drug: Fingolimod 0.5mg/daily Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Fingolimod 0.5mg/daily
Oral capsule dose was given once daily for 48 weeks
Drug: Fingolimod 0.5mg/daily
Other Name: 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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01757691

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United States, Florida
Novartis Investigative Site
St. Petersburg, Florida, United States, 33713
Novartis Investigative Site
Majadahonda, Madrid, Spain, 28222
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01757691    
Other Study ID Numbers: CFTY720D2402
2012-002968-27 ( EudraCT Number )
First Posted: December 31, 2012    Key Record Dates
Results First Posted: May 4, 2015
Last Update Posted: May 4, 2015
Last Verified: April 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Acute demyelinating optic neuritis
Optic neuritis
Additional relevant MeSH terms:
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Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs