drugset / Trial / NCT01707992

The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

NCT01707992

Phase 3 Completed 2199 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2013-02-20
Primary completion
2015-04-13
Completion
2017-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Laquinimod Small molecule 0.6 mg Oral
Subject Laquinimod Small molecule 1.2 mg Oral

Indications