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

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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

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
We found this trial at
27
sites
Sacramento, California 95825
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Atlanta, Georgia 30322
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Aurora, Colorado 80010
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Baltimore, Maryland 21287
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Cleveland, Ohio 44109
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Danbury, Connecticut 06810
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Dover, Delaware 19901
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Durham, North Carolina 27710
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Fairfield, Connecticut 06824
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Houston, Texas 77030
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Miami, Florida 33136
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Miami, FL
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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New York, NY
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Newark, Delaware 19713
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Oklahoma City, Oklahoma 73104
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Philadelphia, Pennsylvania 19102
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Philadelphia, Pennsylvania 19102
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Raleigh, North Carolina 27609
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Richmond, Virginia 23249
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Rochester, New York 14615
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San Francisco, California 94121
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Seattle, Washington 98103
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St. Petersburg, Florida 33713
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Sunrise, Florida 33351
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Torrance, California 90502
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Washington, District of Columbia 20007
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Worcester, Massachusetts 01665
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