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®)

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®).

Timeline

Start

2008-04-24

Primary completion

2011-06-10

Completion

2011-06-10

Outcome

Missed primary endpoint

registry analysis (other test); Placebo vs Laquinimod; p = 0.0746 NCT00605215 ↗

release “Results showed that the BRAVO study did not achieve its primary endpoint of reducing the annualized relapse rate (p=0.075).” tevapharm.com ↗

release “Results showed that the BRAVO study did not achieve its primary endpoint of reducing the annualized relapse rate (p=0.075).” tevapharm.com ↗

Publications

• Falet JR, Durso-Finley J, Nichyporuk B, Schroeter J, Bovis F, Sormani MP, Precup D, Arbel T, Arnold DL. Estimating individual treatment effect on disability progression in multiple sclerosis using deep learning. Nat Commun. 2022 Sep 26;13(1):5645. doi: 10.1038/s41467-022-33269-x.
• Kolb-Sobieraj C, Gupta S, Weinstock-Guttman B. Laquinimod therapy in multiple sclerosis: a comprehensive review. Neurol Ther. 2014 May 6;3(1):29-39. doi: 10.1007/s40120-014-0017-6. eCollection 2014 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Interferon beta-1a	Protein / enzyme biologic	30 ug	Intramuscular
Subject	Laquinimod	Small molecule	0.6 mg	Oral

Indications