NCT01707992

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,199 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Laquinimod	Laquinimod will be administered as per the dose and schedule specified in the respective arms.
DRUG	Placebo	Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.

Timeline

• Start date: 2013-02-20
• Primary completion: 2015-04-13
• Completion: 2017-07-04
• First posted: 2012-10-16
• Last updated: 2021-11-09
• Results posted: 2019-03-13

Locations

284 sites across 30 countries: United States, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Estonia, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Moldova, Montenegro, North Macedonia, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study