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

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride

Criteria

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