A two-year, double-blind, randomized, multicenter, active controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon β-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507556-68-00

Acronym

CFTY720D2311

Enrollment

Registered

2024-04-04

Start date

2013-07-26

Completion date

Unknown

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

Annualized relapse rate (ARR) and time to relapse, The annualized rate of new/newly enlarged T2 lesion, Patients free of new or newly enlarged T2 lesions

Detailed description

The number of Gd-enhanced T1 lesions, Patients free of Gd-enhanced T1 lesions, Number of CUA lesions, Change from baseline in T2 lesion/ T1 hypointense lesion volume, Percent brain volume change

Interventions

DRUGGilenya 0.5 mg hard capsules

DRUGGilenya 0.25 mg hard capsules

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Annualized relapse rate (ARR) and time to relapse, The annualized rate of new/newly enlarged T2 lesion, Patients free of new or newly enlarged T2 lesions	—

Secondary

Measure	Time frame
The number of Gd-enhanced T1 lesions, Patients free of Gd-enhanced T1 lesions, Number of CUA lesions, Change from baseline in T2 lesion/ T1 hypointense lesion volume, Percent brain volume change	—

Countries

France, Germany, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026