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

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

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