Background: Modulation of the endocannabinoid system via monoacylglycerol lipase inhibition with Lu AG06466 (formerly known as ABX-1431) has previously been shown to reduce tics in patients with Tourette syndrome.
Objective: The aim of this study was to evaluate the efficacy and safety of Lu AG06466 in reducing tics, premonitory urges, and comorbidities in patients with Tourette syndrome.
Methods: This was a 12-week, multicenter, randomized, placebo-controlled, double-blind clinical trial of Lu AG06466 given at two dose levels in 49 adults with Tourette syndrome.
Results: Both treatment groups showed improvement on the Total Tic Score of the Yale Global Tic Severity Scale; the mean (95% CI) treatment difference at week 8 of 3.0 (0.1, 5.9) (P = 0.043) favored placebo. No significant differences were seen for other endpoints assessing changes in tic severity, premonitory urges, quality of life, and common psychiatric comorbidities. Treatment with Lu-AG06466 was generally safe.
Conclusions: There was no evidence that Lu AG06466 has efficacy in suppressing tics. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
Trial registration: ClinicalTrials.gov NCT03625453.
Keywords: ABX-1431; Lu AG06466; Tourette syndrome; endocannabinoid modulator; tics.
© 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.