Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 5/5/2014 |
| Start Date: | August 2013 |
| End Date: | December 2016 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
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
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
We found this trial at
27
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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