The Efficacy, Safety, and Tolerability of Laquinimod in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) (CONCERTO)
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|ClinicalTrials.gov Identifier: NCT01707992|
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Laquinimod Drug: Matching Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2199 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)|
|Actual Study Start Date :||February 20, 2013|
|Actual Primary Completion Date :||April 13, 2015|
|Actual Study Completion Date :||July 4, 2017|
Experimental: Laquinimod Dose 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.
Experimental: Laquinimod Dose 1.2 mg
Two capsules containing 0.6 mg laquinimod to be administered orally once daily during both Periods 1 and 2.
NOTE- As of January 2016, this arm has been discontinued.
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|
- Time to Confirmed Disease Progression (CDP) after at least 3 months in Period 1 [ Time Frame: 24 months (Period 1) ]CDP is defined as an increase in Expanded Disability Status Scale (EDSS)
- Percent change in brain volume [ Time Frame: Change from Baseline to 15 Months ]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
- The time to first confirmed relapse during Period 1 [ Time Frame: 24 months (Period 1) ]
- Time to CDP confirmed after at least 6 months [ Time Frame: 24 months (Period 1) ]
- Time to CDP confirmed after at least 9 months [ Time Frame: 24 months (Period 1) ]
- Number of Participants with Adverse Events [ Time Frame: 24 months (Period 1) ]
- Number of Participants with Abnormal Vital Signs [ Time Frame: 24 months (Period 1) ]
- Number of Participants with Abnormal ECG Findings [ Time Frame: 24 months (Period 1) ]
- Number of Participants with Abnormal Clinical Laboratory Parameters [ Time Frame: 24 months (Period 1) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707992
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|Study Director:||Teva Medical Expert, MD||TEVA|