NCT00605215

BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®)

A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon β-1a (Avonex®) in a Rater-blinded Design

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,331 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Laquinimod	Laquinimod will be administered per dose and schedule specified in the arm description.
DRUG	Placebo	Placebo matching to laquinimod will be administered per schedule specified in the arm description.
DRUG	Avonex®	Avonex® will be administered per dose and schedule specified in the arm description.

Timeline

• Start date: 2008-04-24
• Primary completion: 2011-06-10
• Completion: 2011-06-10
• First posted: 2008-01-30
• Last updated: 2022-04-21
• Results posted: 2022-04-21

Locations

170 sites across 19 countries: United States, Bulgaria, Croatia, Czechia, Estonia, Georgia, Germany, Israel, Italy, Lithuania, North Macedonia, Poland, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Ukraine