AbbVie reports ‘positive’ results from Phase 2 ELATE trial

AbbVie (ABBV) announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of onabotulinumtoxinA compared to placebo for the treatment of upper limb essential tremor. The study met its primary endpoint, demonstrating statistically significant improvements in the Tremor Disability Scale-Revised of onabotulinumtoxinA compared to placebo at week 18. Specifically, the onabotulinumtoxinA group showed a greater reduction in TREDS-R total unilateral score compared to placebo, with scores of -2.61 versus -1.61. The study also met all six secondary endpoints. Safety results were generally consistent with the well-established safety profile of onabotulinumtoxinA. Muscular weakness was the most common adverse event, with reported rates of 24.5% in the onabotulinumtoxinA group versus 2.3% in the placebo group. Instances were localized and transient and most were classified as mild or moderate in nature.