CANNAbinoids in the Treatment of TICS (CANNA-TICS) (NCT03087201) | Clinical Trial Compass
CompletedPhase 3
CANNAbinoids in the Treatment of TICS (CANNA-TICS)
Germany98 participantsStarted 2018-04-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Chronic tic disorder or Tourette syndrome according to DSM-5
✓. Age ≥18 years
✓. Total tic score of the Yale Global Tic Severity Scale (YGTSS-TTS) \> 14 for patients with Tourette syndrome or YGTSS-TTS \> 10 for patients with chronic motor or vocal tics only (= CTD)
✓. Clinical Global Impression-Severity Score (CGI-S) ≥ 4
✓. Medication (and stimulation parameters for deep brain stimulation) for tics and comorbidities must be on a stable dose for at least 30 days before entering the study and patient must consent to maintain the stable dose during the study
✓. Signed written informed consent and willingness to comply with treatment and follow-up procedures
✓. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
✓. Prevention of pregnancy:
Exclusion criteria
✕. Comorbid obsessive-compulsive disorder (OCD), attention deficit/hyperactivity disorder (ADHD), depression, anxiety disorder when unstable or in need of an initial adjustment for a therapy
✕. Ongoing behavioural treatment for tics
✕. History of schizophrenia, psychotic, severe personality, or pervasive developmental disorder
✕
What they're measuring
1
Response-rate to treatment according to YGTSS-TTS (Total Tic-Score of the Yale Global Tic Severity Scale [YGTSS])
. Patient has a history of suicidal ideation with intent to act or a plan to act in the 12 months preceding the Screening Visit
✕. Current clinical diagnosis of substance abuse or dependence and compulsive disorder
✕. Secondary tic disorders and other significant neurological disorders that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses added risk for the patient, or confounds the assessment of patient safety
✕. Severe cardiovascular diseases, hepatitis C, or other severe hepatic and renal disorders by history that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses added risk for the patient, or confounds the assessment of patient safety
✕. Any medical condition based on medical history, physical examination, and vital sign measurements that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses added risk for the patient, or confounds the assessment of patient safety