NCT00988052

A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course

A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 839 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 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: 2009-11-10
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2009-10-01
• Last updated: 2021-12-09
• Results posted: 2019-01-08

Locations

135 sites across 23 countries: United States, Austria, Bulgaria, Canada, Czechia, Estonia, France, Georgia, Germany, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Russia, Serbia, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study