None listed
Conditions
Brief summary
Tourette’s syndrome (TS) is a neurological disorder that develops in childhood and often continues into adulthood. Individuals with TS make involuntary movements and vocalisations (known as tics), which may be painful, embarrassing and functionally impairing. There is no cure for TS, but certain medications (particularly antipsychotics) are effective at suppressing tics when taken continuously. Unfortunately, these medications have significant and independently-disabling side effects, which limit their acceptability for many sufferers. The human body has its own (‘endogenous’) cannabinoid neurotransmitter system, which facilitates communication between nerve cells in the brain. This system is implicated in the control of normal movement and the development of movement disorders such as TS. The ‘endocannabinoid’ system could therefore be a new therapeutic target for tic suppression. There is some early evidence to support the effectiveness of cannabinoids in TS, but well-designed clinical trials have yet to be conducted. We plan to use an oral formulation of medicinal cannabis containing two cannabinoids: tetrahydrocannabinol and cannabidiol. This formulation does not intoxicate or cause the unpleasant psychiatric effects of ‘street’ cannabis. We predict that treatment with tetrahydrocannabinol and cannabidiol will significantly reduce tics, when compared to placebo, as well as improving psychiatric and cognitive symptoms associated with TS. We also predict that this formulation will be well tolerated, without psychiatric side effects, and will not lead to craving or intoxication. Therefore, this study may support the development of a new, safe and effective treatment for TS, with potential applications to other neurological disorders.
Interventions
Adults with Tourette's Syndrome will participate in a randomised, double-blinded, placebo-controlled, crossover clinical trial. Each participant will complete two 6-week periods of treatment with either active drug or placebo, with an intervening washout of 4-weeks. The order of presentation of active drug versus placebo will be randomly allocated and counterbalanced in a 1:1 ratio between groups. The active drug will be an oral solution containing 5mg/ml tetrahydrocannabinol (THC) and 5mg/ml ca
Adults with Tourette's Syndrome will participate in a randomised, double-blinded, placebo-controlled, crossover clinical trial. Each participant will complete two 6-week periods of treatment with either active drug or placebo, with an intervening washout of 4-weeks. The order of presentation of active drug versus placebo will be randomly allocated and counterbalanced in a 1:1 ratio between groups. The active drug will be an oral solution containing 5mg/ml tetrahydrocannabinol (THC) and 5mg/ml cannabidiol (CBD). The placebo will be an inert oil. Initial dosing will be 1ml daily, increasing up to a maximum of 4ml daily in divided doses. Dose titration will be overseen by the lead investigator based on standardised evaluation of tic severity. Criteria for dose escalation will be a decrease of less than 2 points, no change or increased tic severity score on the Yale Global Tic Severity Scale. Dose increases will be at the rate of 1ml per week. Participants will be required to return empty bottles of medication at each visit in order to receive a further supply.
Sponsors
Wesley Medical Research Insititute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Confirmed diagnosis of Tourette's syndrome with a tic severity score greater than 20 on the Yale Global Tic Severity Scale. Must agree not to drive a motor vehicle during the trial. Able to give written and informed consent.
Exclusion criteria
History of epilepsy. History of multiple sclerosis. History of an additional movement disorder such as Parkinson's disease. History of dementia.. Pregnancy and breastfeeding. Recreational cannabis smoker (participants must have a negative drug screen at study entry). Current treatment with deep brain stimulation. Current drug or alcohol abuse (excluding tobacco). Any history of psychosis. Diagnosis of bipolar disorder. History of any previous high-lethality suicide attempt, history of any suicide attempt in the last 12-months or at high-risk of suicide in the opinion of the screening clinician. Currently using antipsychotic or dopamine-depleting agents as treatment for Tourette's syndrome. Participants who have undergone a successful 4 week washout of current exclusionary therapies overseen by the Investigator will be eligible. Allergy to tetrahydrocannabinol and cannabidiol or the tablet excipients. Taken another study (experimental) drug within the past 30 days.
Outcome results
None listed