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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response-rate to treatment according to YGTSS-TTS (Total Tic-Score of the Yale Global Tic Severity Scale [YGTSS])
. 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
. 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