AbbVie Says Phase 2 ELATE Trial Met Primary Endpoint For BOTOX To Treat Upper Limb Essential Tremor

(RTTNews) - AbbVie, Inc. (ABBV) announced Monday positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of onabotulinumtoxinA (BOTOX) 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 (TREDS-R) 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.

The safety results were generally consistent with the well-established safety profile of onabotulinumtoxinA.