STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START) (START)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects with relapsing remitting MS with high disease activity despite treatment with a disease modifying therapy (> 1 relapse in the previous year, > 9 hyperintense T2 lesions or > 1 Gd-enhancing lesion or "non-responding" which could be defined as unchanged or increased relapse rate or ongoing severe relapses compared to previous year) or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).
pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception
Other protocol-defined inclusion/exclusion criteria may apply