• 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.
• The trial also met all six secondary endpoints.
• Results from safety analyses were generally consistent with the well-established safety profile of onabotulinumtoxinA.

AbbVie 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

"Essential tremor is a progressive neurological condition that affects millions worldwide and often results in unsatisfactory outcomes with current treatments," said Daniel Mikol, M.D., Ph.D., vice president, neuroscience development, AbbVie. "No new pharmacological treatments have been approved in the U.S. for essential tremor for more than 30 years. These results represent a significant advance and demonstrate further proof of mechanism for a neurotoxin as a potential treatment option to help patients and healthcare providers manage this challenging condition."

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.¹

Results from the study will be presented at the International Congress of Parkinson's Disease and Movement Disorders® on October 8, 2025.

The use of BOTOX® for essential tremor is not approved by the U.S. Food and Drug Administration (FDA) or any other global regulatory authority and its safety and efficacy have not been evaluated by regulatory authorities.