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
patients with multiple sclerosis (MS)
– 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
Key Exclusion Criteria Core Phase:
– 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
Key Inclusion Criteria Extension Phase:
Applies to all patients participating in the Core Phase and then entering the Extension
Phase. 1. Patients that originally met Core Phase Inclusion criteria and completed the Core
phase on or off of study drug.
Applies to patients newly recruited to participate in the Extension Phase.
– All newly recruited patients’ that enroll directly into the Extension Phase must
fulfill the local country health authority product label approved for pediatric age
group for inclusion criteria.
– Central review (including initial MRI report) of the diagnosis of pediatric MS will be
required for all newly recruited patients.
Key Exclusion Criteria Extension Phase:
Applies to patients who completed the Core Phase, but prematurely discontinued study drug.
1. Premature discontinuation of the study drug during the Core Phase due to:
– an adverse event,
– serious adverse event,
– laboratory abnormality
– other conditions leading to permanent study drug discontinuation due to safety
2. Patients with known new events or concomitant medications (washout periods required
prior to Visit 15) that would exclude them from the Core Phase exclusion criteria.
Serological or other additional tests will not be required.
Applies to patients newly recruited in the younger cohort to participate in the Extension
1. All newly recruited patients in the younger cohort that enroll directly into the
Extension Phase must fulfill the exclusion criteria for the core phase.
- Novartis Investigative Site, Los Angeles, California, United States, 90027
- Novartis Investigative Site, San Francisco, California, United States, 94143