This site is intended for healthcare professionals
Clinical trials
  • Home
  • /
  • Clinical trials
  • /
  • Gilenya
  • /
  • Safety and Efficacy of Fingolimod in Pediatric Pat...
Clinical trial

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Read time: 1 mins
Last updated:13th Aug 2023
Identifier: NCT01892722
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis ID: NCT01892722

Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis Pharmaceuticals (Responsible Party)
Last Update Posted: 2023-08-14

Brief Summary:
To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

Detailed Description:
The study is divided into a Core Phase, which includes the Double-Blind Treatment Period, and an Extension Phase in which all patients will be treated with fingolimod. The Core Phase is a 24-month, double-blind, randomized, active-controlled, parallel-group multicenter study phase to evaluate the efficacy and safety of fingolimod compared to IFN β-1a in children/adolescent patients aged 10-17 years old with MS. The Extension Phase is a 60-month (5 year) study phase for patients who complete the Core Phase of the study and meet all inclusion/exclusion criteria and for patients who will be recruited in the younger cohort to participate in the Extension Phase. The 'younger cohort' refers to the population of pediatric patients fulfilling 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). The recruitment of the younger cohort (up to 25 patients) was requested as a post- approval health authority commitment

A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase

Drug: Interferon beta-1a
Drug: Fingolimod
Drug: Placebo capsule
Drug: Placebo i.m. injection

Category Value
Study Start (Actual) 2013-07-26
Primary Completion (Actual) 2017-07-14
Study Completion (Estimated) 2029-07-12
Enrollment (Estimated) 220
Study Type Interventional
Phase Phase 3
Other Study ID Numbers CFTY720D2311
2011-005677-23 (EudraCT Number)

View full details