At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,083 enrolled
Drug / intervention
Fingolimod +1 moredrug
Likely dose
Not stated in 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.
24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
In Brief
A Phase 3 clinical trial evaluating Fingolimod and Placebo for Multiple Sclerosis. Completed, enrolled 1,083 participants across 112 sites in 8 countries.
Detailed Summary
This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesAustralia, Austria, Canada, Poland, Romania, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2006
First PostedJul 2006
Primary CompletionJun 2011
Study CompletionAug 2011
TodayJul 2026
First PostedJul 21, 2006
Enrollment StartJun 1, 2006
Primary CompletionJun 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 19.9 years ago
Interventions
Fingolimoddrug
Fingolimod capsules for oral administration
Placebodrug
Matching placebo capsules for oral administration.