Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
Multiple Sclerosis
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring pediatric, multiple sclerosis, fingolimod, pre-pubertal, low weight, children, adolescent, MS, core phase, extension phase, younger cohort
Eligibility Criteria
Key Inclusion Criteria Core Phase:
- 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 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.
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 reasons
- 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 Phase.
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.
Sites / Locations
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Fingolimod
Interferon beta-1a
Fingolimod-Younger Cohort
Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose. Participants in this arm during core continued into extension and received open-label treatment
An intramuscular (IM) injection of Interferon beta-1a was administered once weekly during core phase. Participants switched to receive open-label fingolimod in extension phase
The 'younger cohort' refers to the new pediatric patients to be recruited in the extension phase who fulfill any single one or a combination of the following criteria: being ≤12 years of age, or weighing ≤40 kg, or being prepubertal (i.e. pubertal status of Tanner stage <2)