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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Acute Demylelinating Optic Neuritis

Intervention / Treatment
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* Drug: Fingolimod 0.5mg/daily
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fingolimod 0.5mg/daily<br>Oral capsule dose was given once daily for 48 weeks | Drug: Fingolimod 0.5mg/daily<br> <br> * Other names: FTY, Gilenya;|
| Placebo Comparator: Placebo<br>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<br> <br> |

What is the study measuring?
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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 | 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) | 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 | 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 | 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 | Number of particpants with Adverse events as a measure of safety and tolerability | Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute demyelinating optic neuritis, Optic neuritis