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 1, Anna Pisarenko 1, Natalia Szejko 2, Martina Haas 1, Carolin Fremer 1, Ewgeni Jakubovski 1, Richard Musil 3, Alexander Münchau 4, Irene Neuner 5, Daniel Huys 6, Ludger Tebartz van Elst 7, Christoph Schröder 8, Rieke Ringlstetter 9, Armin Koch 9, Eva Beate Jenz 9, Anika Großhennig 10
- 1Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hannover, Germany.
- 2Department of Neurology, Medical University of Warsaw, Poland; Department of Bioethics, Medical University of Warsaw, Poland.
- 3Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University Munich, Munich, Germany.
- 4Institute of Systems Motor Science, University of Lübeck, Lübeck, Germany.
- 5Departments of Psychiatry, Psychotherapy, and Psychosomatics, School of Medicine, RWTH Aachen University, Aachen, Germany; Institute of Neuroscience and Medicine (INM-4), Forschungszentrum Jülich, Jülich, Germany; JARA-BRAIN – Translational Medicine, Aachen, Germany.
- 6Department of Psychiatry and Psychotherapy, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany; Department of Psychiatry and Psychotherapy III, LVR Hospital Bonn, Bonn, Germany.
- 7Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
- 8Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.
- 9Institute of Biostatistics, Hannover Medical School, Carl-Neuberg-Str. 1, Hannover 30625, Germany.
- 10Institute of Biostatistics, Hannover Medical School, Carl-Neuberg-Str. 1, Hannover 30625, Germany. Electronic address: Grosshennig.Anika@mh-hannover.de.
Affiliationer
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.
Keywords: ADHD; Cannabis-based medicine; Nabiximols; OCD; Randomized-controlled trial; Tics; Tourette syndrome.
