At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of multiple sclerosis with documented relapsing course (RRMS, SPMS, or PRMS)
- ✓Ambulatory with EDSS score ≤5.5
- ✓At least 1 relapse in the prior year OR at least 2 relapses in the prior 2 years
- ✓Meets McDonald's criteria for MS diagnosis
- ✕Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease
- ✕Significantly impaired bone marrow function
- ✕Pregnant or nursing women
- ✕History of alcohol or drug abuse
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses
In Brief
A Phase 3 clinical trial evaluating Teriflunomide and Placebo (for teriflunomide) for Multiple Sclerosis. Completed, enrolled 1,088 participants across 21 sites in 21 countries.
Detailed Summary
The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: * to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue; * to evaluate the safety and tolerability of teriflunomide.
Study Details
Timeline
Interventions
Film-coated tablet Oral administration
Film-coated tablet Oral administration