This is a multicentre, randomized, double-blind, placebo controlled, parallel-group, phase IIIb trial. Patients (≥18 years) with chronic tic disorders and Tourette syndrome will be recruited. The objective of the trial is to demonstrate that treatment with the cannabis extract nabiximols is superior to placebo in reducing tics and comorbidities in patients with Tourette syndrome and chronic tic disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
98
starting dose (1 puff): 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD), maximum dose (12 puffs): 32.4 mg THC/30 mg CBD, no target dose is defined Duration of treatment: 13 weeks
analogous to experimental intervention
Uniklinik RWTH Aachen, Psychiatry and Psychotherapy
Aachen, Germany
University Hospital Cologne, Psychiatry and Psychotherapy
Cologne, Germany
University of Freiburg, Psychiatry and Psychotherapy
Freiburg im Breisgau, Germany
Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy
Hanover, Germany
Response-rate to treatment according to YGTSS-TTS (Total Tic-Score of the Yale Global Tic Severity Scale [YGTSS])
Time frame: 13 weeks
Fitness to Drive Test
Reaction time and choice reaction (RT)
Time frame: 13 weeks
Fitness to Drive Test
Stress Behavior capacity (DT-Auslastung)
Time frame: 13 weeks
Fitness to Drive Test
Stress Behavior performance quantity (DT Mengenleistung)
Time frame: 13 weeks
Fitness to Drive Test
Concentration (COG)
Time frame: 13 weeks
Fitness to Drive Test
Perceptual speed (ATAVT)
Time frame: 13 weeks
YGTSS-TTS
Time frame: 8 weeks and 1 month after end of treatment (17 weeks)
YGTSS-TTS
Time frame: Baseline and 13 weeks
YGTSS-Global Score (YGTSS-GS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Modified Rush Video-Based Tic Rating Scale (MRVS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
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University Hospital Schleswig-Holstein, Institute of Neurogenetics, Department of Pediatric and Adult Movement Disorders and Neuropsychiatrics
Lübeck, Germany
LMU Munich, Psychiatry and Psychotherapy
Munich, Germany
Clinical Global Impression-Improvement Score (CGI-I)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Clinical Global Impression-Severity Score (CGI-S)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Adult Tic Questionnaire (ATQ)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Tourette Syndrome-Quality of Life Scale (GTS-QoL)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Pre-monitory Urge for Tics Scale (PUTS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Beck Depression Inventory-II (BDI-II)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Conners' Adult ADHD Rating Scale (CAARS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Beck Anxiety Inventory (BAI)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Skala Impulsives-Verhalten-8 (I-8)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
12-item short-form Health Survey (SF-12)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Rage Attacks Questionnaire for Adults with GTS (RAQ-GTS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)