The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,331
Laquinimod will be administered per dose and schedule specified in the arm description.
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Avonex® will be administered per dose and schedule specified in the arm description.
Annualized Rate of Confirmed Relapses
A relapse was defined as the appearance of new neurological abnormalities or the reappearance of previously observed neurological abnormalities; lasting at least 48 hours and immediately preceded by an improved neurological state of ≥30 days from onset of previous relapse, accompanied by observed objective neurological changes (an increase of ≥0.5 in Expanded Disability Status Scale \[EDSS\] score, or an increase of 1 grade in the score of 2 or more of the 7 Functional Systems \[FS\], or an increase of 2 grades in the score of 1 FS as compared to the previous evaluation). Total number of confirmed relapses during the treatment period was divided by the sum of number of days on study in the treatment period and then multiplied by the number of days in the year to calculate the annualized relapse rate. Annualized relapse rate was derived from a baseline-adjusted negative binomial regression.
Time frame: Baseline up to Month 24
Change From Baseline in Disability as Assessed by the Multiple Sclerosis Functional Composite (MSFC) Score
The Multiple Sclerosis Functional Composite is an instrument assessing disability that consists of 3 clinical assessments. The 3 are Timed 25-Foot Walk, 9-Hole Peg Test which measures upper extremity (arm and hand) function, and PASAT (Paced Auditory Serial Addition Test) which is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. A Z-score is used to define a common metric from the 3 assessments that constitute the MSFC score. The study's population at baseline was used as reference population for the Z-score calculation. A Z-score of 0 represents the population mean at baseline. Higher Z-scores correspond to an improved outcome.
Time frame: Baseline, Month 24
Percent Change From Baseline in Brain Volume
Change in brain volume was derived from MRI scans obtained at baseline and at Month 24.
Time frame: Baseline, Month 24
Accumulation of Physical Disability Measured by the Number of Participants With Confirmed Progression of EDSS
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Teva Investigational Site 1267
Birmingham, Alabama, United States
Teva Investigational Site 1237
Phoenix, Arizona, United States
Teva Investigational Site 1252
Phoenix, Arizona, United States
Teva Investigational Site 1279
Phoenix, Arizona, United States
Teva Investigational Site 1276
Tucson, Arizona, United States
Teva Investigational Site 1272
Pasadena, California, United States
Teva Investigational Site 1238
Sacramento, California, United States
Teva Investigational Site 1280
Aurora, Colorado, United States
Teva Investigational Site 1255
Orlando, Florida, United States
Teva Investigational Site 1282
Sarasota, Florida, United States
...and 160 more locations
A confirmed progression of EDSS was defined as a 1 point increase from baseline on EDSS score if baseline EDSS was between 0 and 5.0, or a 0.5 point increase if baseline EDSS was 5.5, confirmed 3 months later. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]). Data is presented as distribution of confirmed progression (number of participants with confirmed progression of EDSS) sustained for 3 months. Progression could not be confirmed during a relapse.
Time frame: Baseline up to Month 24