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In this international, randomized, double-blind, manufacturer-funded, phase III study (the PreCISe trial), researchers compared glatiramer acetate (GA) with placebo to treat patients with a clinically isolated syndrome, who are at high risk for multiple sclerosis (MS). Researchers randomized patients aged 15 to 45 to daily, subcutaneous GA (N=243) or placebo (N=238) injections, within 90 days of a unifocal clinically isolated syndrome (such as monocular optic neuritis or incomplete transverse myelitis). All had at least two brain lesions ≥6 mm in diameter. The 3-year trial terminated early, at a preplanned interim analysis at 2.3 years.
Among the quarter of participants who had a second attack, the primary outcome — time to second clinical a…