CANNA-TICS: Efficacy and safety of oral treatment with nabiximols in adults with chronic tic disorders - Results of a prospective, multicenter, randomized, double-blind, placebo controlled, phase IIIb superiority study.
Kirsten R Müller-vahl, Anna Pisarenko, Natalia Szejko, Martina Haas, Carolin Fremer, Ewgeni Jakubovski, Richard Musil, Alexander Münchau, Irene Neuner, Daniel Huys, Ludger Tebartz Van Elst, Christoph Schröder, Rieke Ringlstetter, Armin Koch, Eva Beate Jenz, Anika Großhennig
Psychiatry research May 1, 2023 DOI: 10.1016/j.psychres.2023.115135 via PubMed
Summary
A randomized, placebo-controlled phase IIIb trial tested the cannabis extract nabiximols in 97 adults with Tourette syndrome or chronic tic disorders. Although 21.9% of those receiving nabiximols achieved a 25% or greater reduction in tics compared to 9.1% on placebo, the difference was not statistically significant. Secondary analyses showed trends toward improvement in tics, depression, and quality of life. Exploratory subgroup analyses suggested that males, patients with more severe tics, and those with comorbid ADHD may benefit more. No major safety concerns arose.
Study at a glance
| Characteristics | Randomized controlled trial Placebo-controlled Double-blind Peer reviewed |
|---|---|
| Sample size | 97 |
| Population | Adults with Tourette syndrome or chronic tic disorders |
| Keywords | ADHD Cannabis-based medicine Nabiximols OCD Randomized-controlled trial |
| Citations | 36 |
| Key finding | Nabiximols did not demonstrate statistically significant superiority over placebo for the primary endpoint of a 25% tic reduction, though trends for improvement were observed in secondary and exploratory analyses. |
Abstract
Preliminary data suggest that cannabis-based medicines might be a promising new treatment for patients with Tourette syndrome (TS)/chronic tic disorders (CTD) resulting in an improvement of tics, comorbidities, and quality of life. This randomized, multicenter, placebo-controlled, phase IIIb study aimed to examine efficacy and safety of the cannabis extract nabiximols in adults with TS/CTD (n = 97, randomized 2:1 to nabiximols:placebo). The primary efficacy endpoint was defined as a tic reduction of ≥ 25% according to the Total Tic Score of the Yale Global Tic Severity Scale after 13 weeks of treatment. Although a much larger number of patients in the nabiximols compared to the placebo group (14/64 (21·9%) vs. 3/33 (9·1%)) met the responder criterion, superiority of nabiximols could formally not be demonstrated. In secondary analyses, substantial trends for improvements of tics, depression, and quality of life were observed. Additionally exploratory subgroup analyses revealed an improvement of tics in particular in males, patients with more severe tics, and patients with comorbid attention deficit/hyperactivity disorder suggesting that these subgroups may benefit better from treatment with cannabis-based medication. There were no relevant safety issues. Our data further support the role of cannabinoids in the treatment of patients with chronic tic disorders.