CANNAbinoids in the Treatment of TICS (CANNA-TICS)

Inclusion Criteria:

1. Chronic tic disorder or Tourette syndrome according to DSM-5
2. Age ≥18 years
3. Total tic score of the Yale Global Tic Severity Scale (YGTSS-TTS) > 14 for patientswith Tourette syndrome or YGTSS-TTS > 10 for patients with chronic motor or vocal ticsonly (= CTD)
4. Clinical Global Impression-Severity Score (CGI-S) ≥ 4
5. Medication (and stimulation parameters for deep brain stimulation) for tics andcomorbidities must be on a stable dose for at least 30 days before entering the studyand patient must consent to maintain the stable dose during the study
6. Signed written informed consent and willingness to comply with treatment and follow-upprocedures
7. Patients capable of understanding the investigational nature, potential risks andbenefits of the clinical trial
8. Prevention of pregnancy: Women without childbearing potential defined as follows:

• at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateraloophorectomy or
• hysterectomy or uterine agenesis or
• ≥ 50 years and in postmenopausal state ≥ 1 year or
• < 50 years and in postmenopausal state ≥ 1 year with urine FSH > 40 IU/l and urineoestrogen < 30 ng/l or a negative oestrogen test or Women of childbearing potential with a negative urine ß-HCG pregnancy test at screening whoagree to meet one of the following criteria from the time of screening, during the studyand for a period of three months following the last administration of study medication:
• correct use of contraception methods. The following are acceptable: hormonalcontraceptives (combined oral contraceptives, oestrogen-free pills with desogestrel,implants, transdermal patches, hormonal vaginal devices or injections with prolongedrelease), intrauterine device (IUS)
• true abstinence (periodic abstinence and withdrawal are not acceptable methods ofcontraception)
• sexual relationship only with female partners and/or sterile male partners or Maleswho are not surgically sterile and who are sexually active with female partner(s) ofchildbearing potential must agree to correct use of one of the following contraceptionmethods from the time of screening, during the study and for a period of three monthsfollowing the last administration of study medication: hormonal contraceptives (combined oral contraceptives, oestrogen-free pills with desogestrel, implants,transdermal patches, hormonal vaginal devices or injections with prolonged release),intrauterine device (IUS)

Exclusion Criteria:

1. Comorbid obsessive-compulsive disorder (OCD), attention deficit/hyperactivity disorder (ADHD), depression, anxiety disorder when unstable or in need of an initial adjustmentfor a therapy
2. Ongoing behavioural treatment for tics
3. History of schizophrenia, psychotic, severe personality, or pervasive developmentaldisorder
4. Patient has a history of suicidal ideation with intent to act or a plan to act in the 12 months preceding the Screening Visit
5. Current clinical diagnosis of substance abuse or dependence and compulsive disorder
6. Secondary tic disorders and other significant neurological disorders that, in theopinion of the investigator, might interfere with the patient's participation in thestudy, poses added risk for the patient, or confounds the assessment of patient safety
7. Severe cardiovascular diseases, hepatitis C, or other severe hepatic and renaldisorders by history that, in the opinion of the investigator, might interfere withthe patient's participation in the study, poses added risk for the patient, orconfounds the assessment of patient safety
8. Any medical condition based on medical history, physical examination, and vital signmeasurements that, in the opinion of the Investigator, might interfere with thepatient's participation in the study, poses added risk for the patient, or confoundsthe assessment of patient safety
9. Use of cannabis or cannabinoid-based medicine (CBM) in the 30-day period prior tostudy entry and/or positive delta-9-tetrahydrocannabinol (THC) urine test
10. Positive urine pregnancy test
11. Pregnancy or lactation period
12. The subject has received any investigational medication or used any investigationaldevice within 30 days prior to the first dose of study medication or is activelyparticipating in any investigational drug or device study, or is scheduled to receivean investigational drug or to use an investigational device during the course of thestudy.
13. Known or suspected hypersensitivity to any of the active substances or any excipientsof the investigational medicinal product