AbbVie's BOTOX Meets Primary And All Secondary Endpoints In Phase 2 ELATE Trial For Upper Limb Essential Tremor

Author: Benzinga Newsdesk | October 06, 2025 09:06am

• OnabotulinumtoxinA (BOTOX®) met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo.1
• The trial also met all six secondary endpoints.2
• Results from safety analyses were generally consistent with the well-established safety profile of onabotulinumtoxinA.1

NORTH CHICAGO, Ill., Oct. 6, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced 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, (p=0.029).1 The study also met all six secondary endpoints.2

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