At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 920 enrolled
Drug / intervention
Fingolimod 0.5 mg +1 moredrug
Likely dose
Fingolimod 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
In Brief
A Phase 3 clinical trial evaluating Fingolimod 0.5 mg and Fingolimod 1.25 mg for Multiple Sclerosis. Completed, enrolled 920 participants across 103 sites in 22 countries.
Detailed Summary
This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesAustralia, Belgium, Canada, Czechia, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Netherlands, Poland, Romania, Russia, Slovakia, South Africa, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedApr 2008
Primary CompletionJun 2011
TodayJul 2026
First PostedApr 21, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.2 years ago
Interventions
Fingolimod 0.5 mgdrug
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Fingolimod 1.25 mgdrug
Patients self-administered fingolimod 1.25 mg capsules orally once daily.