Kirsten R Müller-Vahl1, Carolin Fremer1, Chan Beals2, Jelena Ivkovic3, Henrik Loft3, Christoph Schindler4. 1. Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hannover, Germany. 2. Abide Therapeutics, San Diego, California, USA. 3. H. Lundbeck A/S, Valby, Denmark. 4. Clinical Research Center Core Facility, Hannover Medical School, Hannover, Germany.
Abstract
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.
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.
Authors: Alba Navarro-Romero; Lorena Galera-López; Paula Ortiz-Romero; Alberto Llorente-Ovejero; Lucía de Los Reyes-Ramírez; Iker Bengoetxea de Tena; Anna Garcia-Elias; Aleksandra Mas-Stachurska; Marina Reixachs-Solé; Antoni Pastor; Rafael de la Torre; Rafael Maldonado; Begoña Benito; Eduardo Eyras; Rafael Rodríguez-Puertas; Victoria Campuzano; Andres Ozaita Journal: Elife Date: 2022-10-11 Impact factor: 8.713