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Study design: 2-year randomised, double-blind trial period and a 5-year extension phase in which all patients were treated with fingolimod.
Setting: 105 study locations worldwide.
Patients: 215 patients, 10–17 years of age with relapsing multiple sclerosis (MS) or who had evidence of one or more gadolinium-enhancing (Gd+) lesion on T1-weighted MRI within the 6 months prior to randomisation.
Intervention: oral fingolimod 0.5 mg per day or intramuscular interferon beta-1a (INF B-1a) at dose of 30 ug per week for up to 2 years, 1:1 allocation. …
Review of article Arnold DL, Banwell B, Bar-Or A et al. Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: Results from the phase 3 PARADIGMS study. J Neurol Neurosurg Psychiatry. 2020;91:483–92.
Provenance and peer review Not commissioned; internally peer reviewed.