-
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
"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.
About the ELATE Study
The ELATE trial was a Phase 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of upper limb essential tremor in adults. The primary efficacy measure was the change in the Tremor Disability Scale-Revised (TREDS-R) total score across seven unilateral items from baseline across weeks 15, 18 and 21. Secondary outcome measures included activity of daily living assessment, various tremor assessment scales and global impression of severity scores.
About Essential Tremor
Essential tremor is the most common movement disorder, impacting approximately 25–60 million individuals worldwide.3 This condition complicates physical activities due to uncontrollable and involuntary action tremors and furthermore often results in depression, anxiety and social embarrassment, thereby affecting overall quality of life.4 Current treatment options are limited in both efficacy and tolerability often leaving patients with few viable options.
About BOTOX® (onabotulinumtoxinA)
BOTOX® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Today, BOTOX® is FDA-approved for multiple therapeutic indications, including chronic migraine, overactive bladder, leakage of urine (incontinence) due to detrusor overactivity associated with a neurologic condition in adults and in pediatric patients five years of age and older, cervical dystonia, adult and pediatric spasticity, and severe underarm sweating (axillary hyperhidrosis). BOTOX® is not FDA-approved for essential tremor.