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

Use our guide to learn which trials are right for you!

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