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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Trial Summary
Trial Overview
Inclusion Criteria

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
Novartis Investigative Site
Sunrise, Florida 33351
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Novartis Investigative Site
Atlanta, Georgia 30322
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Atlanta, GA
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Novartis Investigative site
Aurora, Colorado 80010
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Aurora, CO
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Novartis
Baltimore, Maryland 21287
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Baltimore, MD
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Novartis Investigative Site
Cleveland, Ohio 44109
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Cleveland, OH
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Novartis Investigative Site
Danbury, Connecticut 06810
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Danbury, CT
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Novartis Investigative Site
Dover, Delaware 19901
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Dover, DE
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Novartis Investigative Site
Durham, North Carolina 27710
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Durham, NC
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Novartis Investigative Site
Fairfield, Connecticut 06824
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Fairfield, CT
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Novartis Investigative Site
Houston, Texas 77030
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Houston, TX
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Novartis Investigative Site
Miami, Florida 33136
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Miami, FL
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Novartis
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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Novartis
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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Novartis Investigative Site
Newark, Delaware 19713
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Newark, DE
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Novartis Investigative Site
Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Novartis Investigative Site
Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Novartis Investigative Site
Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Novartis Investigative Site
Raleigh, North Carolina 27609
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Raleigh, NC
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Novartis Investigative Site
Richmond, Virginia 23249
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Richmond, VA
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Novartis Investigative Site
Rochester, New York 14615
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Rochester, NY
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Novartis Investigative Site
Sacramento, California 95825
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Sacramento, CA
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Novartis Investigative Site
San Francisco, California 94121
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San Francisco, CA
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Novartis Investigative Site
Seattle, Washington 98103
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Seattle, WA
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Novartis Investigative Site
St. Petersburg, Florida 33713
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St. Petersburg, FL
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Novartis Investigative Site
Torrance, California 90502
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Torrance, CA
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Novartis Investigative Site
Washington, District of Columbia 20007
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Washington,
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Novartis Investigative Site
Worcester, Massachusetts 01665
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Worcester, MA
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