At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,272 enrolled
Drug / intervention
Fingolimod 1.25 mg +2 moredrug
Likely dose
Fingolimod 1.25 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.
A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 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 1.25 mg, Fingolimod 0.5 mg, and 1 other intervention for Relapsing-remitting Multiple Sclerosis. Completed, enrolled 1,272 participants across 115 sites in 19 countries.
Detailed Summary
This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing-remitting Multiple Sclerosis
CountriesAustralia, Belgium, Canada, Czechia, Finland, France, Germany, Greece, Israel, Lithuania, Netherlands, Poland, Russia, Slovakia, South Africa, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedFeb 2006
Primary CompletionJul 2009
TodayJul 2026
First PostedFeb 10, 2006
Enrollment StartJan 1, 2006
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.4 years ago
Interventions
Fingolimod 1.25 mgdrug
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Fingolimod 0.5 mgdrug
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Placebodrug
Patients self-administered a fingolimod placebo capsule orally once daily.