NCT01047319

A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis

A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,047 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Laquinimod	One capsule containing 0.6 mg laquinimod to be administered orally once daily.

Timeline

• Start date: 2010-05-27
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2010-01-12
• Last updated: 2021-12-09
• Results posted: 2019-01-09

Locations

144 sites across 18 countries: United States, Bulgaria, Croatia, Czechia, Estonia, Georgia, Germany, Israel, Italy, Lithuania, North Macedonia, Poland, Romania, Russia, Slovakia, South Africa, Spain, Ukraine

Regulatory

• FDA-regulated drug study