This is a single site, pilot double-blind, randomized, placebo-controlled, cross-over study of 10 participants comparing medicinal cannabis (THC:CBD 10:15 oil) with placebo in reducing tics in adolescents aged 12 - 18 years with severe Tourette Syndrome (TS). The primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, study duration, study procedures, study medication tolerance and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomized controlled trial of THC:CBD 10:15 oil to reduce tic severity in adolescents with TS. The secondary objective of this study is to collect preliminary data on the safety of oral THC:CBD 10:15 oil in adolescents aged 12 to 18 years with TS. As an exploratory aim data from clinician- and parent-rated measures will be compared across the phases to explore for a signal of efficacy on primary (tic reduction) and secondary (premonitory urges, obsessive compulsive behaviors, Attention Deficit Hyperactivity Disorder \[ADHD\] symptoms) outcome measures.
Age range
12 Years – 18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Rate of study participant recruitment, calculated as the time required to reach a sample size of 10.
Timeframe: From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.
Participant withdrawal rate, calculated as the number of participants who withdraw from the trial as a proportion of the total number of participants randomized.
Timeframe: Day 1 to day 176 (end of treatment period 2)
Study medication tolerability, as indicated by the proportion of participants who tolerate the protocol dosing schedule.
Timeframe: Day 1 to day 176 (end of treatment period 2)
Participant adherence to the study medication dosing schedule, calculated as the proportion of participants who demonstrate acceptable medication compliance.
Timeframe: Day 78 (end of treatment period 1) and day 176 (end of treatment period 2)
Study visit attendance, calculated as the proportion of visits completed across the study sample.
Timeframe: Screening to day 169 (final study visit)
Blood test completion, calculated as the proportion of blood tests completed across the study sample.
Timeframe: Screening to day 169 (final study visit)
Parent questionnaire completion, calculated as the proportion of parent-report questionnaires completed across the study sample.
Timeframe: Screening to day 169 (final study visit)
Self-report questionnaire completion, calculated as the proportion of adolescent self-report questionnaires completed across the study sample.
Timeframe: Screening to day 169 (final study visit)
Study design acceptability will be evaluated through a parent-completed study specific evaluation questionnaire completed at the end of the study.
Timeframe: Day 197