The Efficacy and Safety and Tolerability of Laquinimod in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) (CONCERTO)
This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod 0.6 mg/day or 1.2mg/day in subjects with RRMS.
January 01, 1900
Neuroscience - Multiple Sclerosis
Peiqing Qian, MD
Key Inclusion criteria:
- Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
- Subjects must be ambulatory with Kurtzke EDSS score of 0- 5.5 in both screening and randomization visits.
- Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
- Subjects must have experienced at least one documented relapse in the 12 months prior to randomization.
- Subjects must be between 18 and 55 years of age at screening, inclusive.
- Subjects must have disease duration of at least 6 months, but not more than 12 years (from the first symptom) prior to randomization.
Beena Gangadharan and Caryl Tongco