Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial.

ABSTRACT:

Background

In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. First dose administration of fingolimod is associated with a transient, dose-dependent decrease in heart rate (HR) in the 6 hours after drug intake.The aim of the study is to to assess safety and tolerability of the first dose of fingolimod in a cohort of Italian patients with RRMS without alternative therapeutic options.

Methods

Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and had their vital signs monitored hourly. Extended on-site monitoring was provided when required.

Results

Of the 906 patients enrolled in the study, most (95.2%) did not experience any adverse event (

SUBMITTER: Laroni A 

PROVIDER: S-EPMC4005629 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature