At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 742 enrolled
Drug / intervention
Teriflunomide (HMR1726)drug
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.
Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses
In Brief
A Phase 3 clinical trial evaluating Teriflunomide (HMR1726) for Multiple Sclerosis. Completed, enrolled 742 participants across 116 sites in 21 countries.
Detailed Summary
The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse. The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesAustria, Canada, Chile, Czechia, Denmark, Estonia, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedDec 2008
Primary CompletionDec 2015
TodayJul 2026
First PostedDec 5, 2008
Enrollment StartOct 1, 2006
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 17.6 years ago
Interventions
Teriflunomide (HMR1726)drug
Tablet, oral administration QD.