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 |
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
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
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