At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multinational, Double-Blind, Placebo-Controlled, Parallel-Group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Interferon-beta in Subjects With Multiple Sclerosis.
In Brief
A Phase 2 clinical trial evaluating Teriflunomide, Placebo (for Teriflunomide), and 1 other intervention for Multiple Sclerosis. Completed, enrolled 118 participants across 5 sites in 5 countries.
Detailed Summary
The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of interferon-β \[IFN-β\]. Secondary objectives were: * to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue; * to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of IFN-β.
Study Details
Timeline
Interventions
Film-coated tablet Oral administration
Film-coated tablet Oral administration
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection