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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Acute Demylelinating Optic Neuritis

In brief

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

Key facts

Study ID

NCT01757691

Run by

Novartis Pharmaceuticals

People needed

2

Starts

2013-08-01

Expected to finish

2014-05-01

Last updated by the study team

2015-05-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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