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CONCERTO: A randomized, placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis
- Source :
- Multiple sclerosis (Houndmills, Basingstoke, England). 28(4)
- Publication Year :
- 2021
-
Abstract
- Background: Interventions targeting the adaptive immune response are needed in multiple sclerosis (MS). Objective: Evaluate laquinimod’s efficacy, safety, and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: CONCERTO was a randomized, double-blind, placebo-controlled, phase-3 study. RRMS patients were randomized 1:1:1 to receive once-daily oral laquinimod 0.6 or 1.2 mg or placebo for ⩽24 months ( n = 727, n = 732, and n = 740, respectively). Primary endpoint was time to 3-month confirmed disability progression (CDP). The laquinimod 1.2-mg dose arm was discontinued (1 January 2016) due to cardiovascular events at high doses. Safety was monitored throughout the study. Results: CONCERTO did not meet the primary endpoint of significant effect with laquinimod 0.6-mg versus placebo on 3-month CDP (hazard ratio: 0.94; 95% confidence interval: 0.67–1.31; p = 0.706). Secondary endpoint p values were nominal and non-inferential. Laquinimod 0.6 mg demonstrated 40% reduction in percent brain volume change from baseline to Month 15 versus placebo ( p Conclusion: Laquinimod 0.6 mg demonstrated only nominally significant effects on clinical relapses and magnetic resonance imaging (MRI) outcomes and was generally well tolerated. Clinical trial registration number: ClinicalTrials.gov (NCT01707992).
- Subjects :
- medicine.medical_specialty
Multiple Sclerosis
Placebo-controlled study
Quinolones
Cytidine Diphosphate
Multiple sclerosis
chemistry.chemical_compound
Multiple Sclerosis, Relapsing-Remitting
Double-Blind Method
Recurrence
Internal medicine
medicine
Humans
Disability progression
In patient
business.industry
medicine.disease
relapsing-remitting
Magnetic Resonance Imaging
laquinimod
disability progression
Neurology
Tolerability
chemistry
Relapsing remitting
Neurology (clinical)
business
Laquinimod
Subjects
Details
- ISSN :
- 14770970
- Volume :
- 28
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Multiple sclerosis (Houndmills, Basingstoke, England)
- Accession number :
- edsair.doi.dedup.....61d7faf1fb2af9952293a5c9169f6bd8