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.
Multiple Sclerosis (MS)
Drug: Laquinimod 0.6 mg
Drug: Matching Placebo
Drug: Laquinimod 1.2 mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod (0.6 mg/d or 1.2 mg/d) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)|
- Time to Confirmed Disease Progression (CDP) in Period 1 [ Time Frame: 24 months (Period 1) ] [ Designated as safety issue: No ]CDP is defined as an increase in Kurtzke's Expanded Disability Status Scale (EDSS) of 1 point or more from baseline for subjects with baseline EDSS of ≤5.0, or an increase 0.5 points or more from baseline for subjects with baseline EDSS of 5.5. The EDSS rates a person's disability due to multiple sclerosis severity, ranging from 0 (normal neurological exam) to 10 (death due to MS). The higher score represents more severe disability. The outcome measure is the time recorded from Baseline until the subject meets this definition of CDP.
- Percent change in brain volume [ Time Frame: Change from Baseline to 15 Months ] [ Designated as safety issue: No ]This is a measure of brain volume and will be assessed by an MRI. Brain atrophy is defined as the percent change in brain volume from baseline to month 15
- Number of Participants with Adverse Events [ Time Frame: 24 months (Period 1) ] [ Designated as safety issue: Yes ]
- Number of Participants with Abnormal Vital Signs [ Time Frame: 24 months (Period 1) ] [ Designated as safety issue: Yes ]
- Number of Participants with Abnormal ECG Findings [ Time Frame: 24 months (Period 1) ] [ Designated as safety issue: Yes ]
- Number of Participants with Abnormal Clinical Laboratory Parameters [ Time Frame: 24 months (Period 1) ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Experimental: Laquinimod 0.6 mg
Two capsules, one containing 0.6 mg laquinimod and the other containing matching placebo, to be administered orally once daily during both Periods 1 and 2.
|Drug: Laquinimod 0.6 mg|
Experimental: Laquinimod 1.2 mg
Two capsules containing 0.6 mg laquinimod to be administered orally once daily during both Periods 1 and 2.
|Drug: Laquinimod 1.2 mg|
Placebo Comparator: Placebo
Two capsules containing placebo (matching to the 0.6 mg) to be administered orally once daily during Period 1.
|Drug: Matching Placebo|
Eligible subjects with confirmed relapsing-remitting multiple sclerosis will be randomized in a 1:1:1 ratio into one of the following treatment arms: Laquinimod capsules 0.6 mg, Laquinimod capsules 1.2 mg and matching placebo. The study will be comprised of two treatment periods:
Period 1: Double-blind Placebo-controlled (DBPC) period: at least 15 months, but not more than 24 months of once-daily, oral administration of either laquinimod 0.6 mg, 1.2 mg or matching oral placebo.
The Sponsor will declare closing of Period 1 for all subjects when all ongoing enrolled subjects completed at least 15 months in Period 1.
Period 2: Active-treatment (AT) period: 24 months In this period, subjects who were assigned to either 0.6 mg or 1.2 mg daily oral laquinimod during Period 1 (DBPC) will continue with the same treatment assignment, whereas those who were assigned to placebo will receive 1.2 mg daily oral laquinimod.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707992
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|Study Director:||Teva Medical Expert, MD||TEVA|