Two-year, Double-blind, Randomzied, Multicenter, Active-controlled Study to Evaluate Safety and Efficacy of Oral Fingolimod Versus Interferon Beta-1a i.m. in Pediatric Patients With Multiple Sclerosis
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 24 Jan 2018
At a glance
- Drugs Fingolimod (Primary) ; Interferon beta-1a
- Indications Multiple sclerosis
- Focus Registrational; Therapeutic Use
- Acronyms PARADIGMS
- Sponsors Novartis
- 24 Jan 2018 Based on the data from this trial Gilenya (fingolimod) received FDA Breakthrough Therapy designation for relapsing forms of multiple sclerosis in the pediatric patient population, following the submission of Gilenya for a pediatric MS indication to both FDA and EMA, as reported in a Novartis media release.
- 18 Dec 2017 According to a Novartis media release, Dr. Tanuja Chitnis from Massachusetts General Hospital, Boston, US is the principal investigator for this study.
- 28 Oct 2017 Results published in a Novartis media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History