Study Evaluates Botox as Essential Tremor Treatment

Treatment with Botox (onabotulinumtoxinA; AbbVie, North Chicago, IL) was associated with significant improvements in functional outcomes in people with upper limb essential tremor (ET) compared with placebo in study results presented at the 2025 International Congress of Parkinson’s Disease and Movement Disorders. The phase 2 ELATE clinical trial (NCT05216250) met its primary end point and all 6 secondary end points with a safety profile consistent with prior use of Botox in neurologic disorders.

ELATE was a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Botox treatment in adults with ET affecting the upper limbs. In the study, 182 participants were randomized 1:1 into 2 groups with similar baseline demographics, 1 group receiving Botox (n=95) and the other receiving placebo (n=87). The primary efficacy end point was change in Tremor Disability Scale-Revised (TREDS-R) score from baseline to week 18.

Key findings presented at the conference include the following:

• In terms of the primary end point, there was a significant improvement in TREDS-R score at week 18, with a least squares mean change from baseline (CFB) of -2.61 for those receiving Botox and -1.61 for those receiving placebo (95% CI, -1.90 to -0.11; P=.029).
• All 6 secondary end points were met, which included:
• CFB in the Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) Activities of Daily Living (ADL) score across 5 unilateral items.
• CFB in TETRAS Archimedes Spiral score.
• CFB in TETRAS Handwriting score.
• CFB in Clinical Global Impression of Severity (CGI-S).
• CFB in Patient Global Impression of Severity (PGI-S).
• CFB in TETRAS Upper Limb (UL) Scale score.
• Adverse events (AEs) were consistent with known safety data; the most common AE was mild to moderate transient muscle weakness (24.5% in the Botox group vs 2.3% in placebo).

Source: AbbVie. AbbVie announces positive topline results from phase 2 ELATE trial evaluating onabotulinumtoxinA (Botox) for the treatment of upper limb essential tremor. PR Newswire. Published October 6, 2025. Accessed October 8, 2025. https://prnmedia.prnewswire.com/news-releases/abbvie-announces-positive-topline-results-from-phase-2-elate-trial-evaluating-onabotulinumtoxina-botox-for-the-treatment-of-upper-limb-essential-tremor-302575398.html