Expression of Interest: Tourette’s Syndrome Clinical Trial

 Tourette’s syndrome is a neurological disorder that develops in childhood and often continues into adulthood. Individuals with Tourette’s syndrome make involuntary movements and vocalisations (known as tics), which may be painful, embarrassing and functionally impairing. There is no cure for Tourette’s syndrome, 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.

With the support of our donors, we can continue to bring advanced treatments and breakthrough therapies to the community. By participating in a clinical trial, you help improve our community’s access to cutting-edge medicine.

We are currently recruiting for the medicinal cannabis trial for Tourette’s syndrome at Wesley Medical Research, Brisbane. This is the only site for this trial.

If you are interested in taking part, please read the information below and complete your details and our Clinical Trials team will be in contact with you.

About the Trial

 

Project aim

The aim is to conduct a robust, randomised trial, placebo-controlled, double blinded trial of medicinal cannabis for the treatment of Tourette’s syndrome, with a focus on efficacy (tic reduction), safety (adverse events) and tolerability (psychiatric and cognitive symptoms).

Eligibility Criteria

To be enrolled in the study, participants must meet all of the following criteria:

  • Male or female volunteers aged 18 to 70 years of age.
  • History of Tourette’s Syndrome with minimum total tic score of 20 out of 50 on YGTSS         
  • Healthy as assessed by medical history.
  • A female participant is eligible to participate if she is:
      • Of Non-childbearing potential defined as (1) having a documented tubal ligation at least 6 weeks prior to dosing; (2) having had a surgical bilateral oophorectomy (with or without hysterectomy); (3) at least 12 months of spontaneous amenorrhoea with follicle stimulating hormone (FSH) > 40 MIU/mL.
      • Not breastfeeding
      • Of Child-bearing potential with negative urine pregnancy test at screening and negative urine pregnancy test at check-in (Day 1), AND; Agrees to abstain from sexual intercourse, or to use condoms plus one other acceptable form of contraception: i.e. intra-uterine device, hormonal contraception, or a female diaphragm, until 4 weeks after dosing with study drug  OR has only same-sex partners, when this is her preferred and usual lifestyle.
  • Male participant with female partners of childbearing potential must agree to use condoms for the duration of the study and until 4 weeks after dosing with the study drug.
  • Able to give written informed consent.
  • In the opinion of the Investigator able to comply with study procedures and activities.
  • Participant agrees not to drive during the trial and observe other study restrictions.

Details about the study

Wesley Medical Research is running the trial and requires 24 participants.

The study duration will be 28 weeks. Screening will be followed by two treatment periods of six (6) weeks with a four (4) week washout period in between. 

There will be a follow-up visit 3 months post-treatment completion.

Register your interest