At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
In Brief
A Phase 3 clinical trial evaluating Laquinimod and Placebo for Multiple Sclerosis. Completed, enrolled 2,199 participants across 284 sites in 30 countries.
Detailed Summary
This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).
Study Details
Timeline
Interventions
Laquinimod will be administered as per the dose and schedule specified in the respective arms.
Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.