NCT01404117

A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability and efficacy of two daily doses of oral laquinimod (0.6mg or 1.2mg) in adjunct to glatiramer acetate (GA) or interferon-beta (IFN-B) in relapsing remitting multiple sclerosis (RRMS) subjects

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Laquinimod 0.6	Laquinimod 0.6 capsule
DRUG	Laquinimod 1.2	Placebo
OTHER	Glatiramer Acetate or interferon-beta+ Placebo	GA 20 mg/1mL or IFN-B (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®) + oral daily placebo

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2011-07-27
• Last updated: 2013-08-27