Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis



Status:Active, not recruiting
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:10 - 17
Updated:2/28/2019
Start Date:July 26, 2013
End Date:March 15, 2023

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A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase

To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric
patients with multiple sclerosis


Key Inclusion Criteria:

- diagnosis of multiple sclerosis

- at least one MS relapse during the previous year or two MS relapses in the previous 2
years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to
5.5, inclusive

Key Exclusion Criteria:

- patients with progressive MS

- patients with an active, chronic disease of the immune system other than MS

- patients meeting the definition of ADEM

- patients with severe cardiac disease or significant findings on the screening ECG.

- patients with severe renal insufficiency
We found this trial at
13
sites
Orlando, Florida 32806
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Orlando, FL
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Birmingham, Alabama 35209
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Birmingham, AL
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Boston, Massachusetts 02118
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Boston, MA
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Boston, Massachusetts 02118
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Boston, MA
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Detroit, Michigan 48202
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Detroit, MI
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Los Angeles, California 90095
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Los Angeles, CA
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Miami, Florida 33136
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Miami, FL
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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Parkville, Victoria
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Parkville,
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Salt Lake City, Utah 84103
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Salt Lake City, UT
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San Francisco, California 94121
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San Francisco, CA
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Tallahassee, Florida 32308
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Tallahassee, FL
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