Status:
COMPLETED
Is Medicinal Cannabis an Effective Treatment for Tourette Syndrome in Adolescents? a Pilot Study
Lead Sponsor:
Murdoch Childrens Research Institute
Conditions:
Tourette Syndrome in Adolescence
Eligibility:
All Genders
12-18 years
Phase:
PHASE1
PHASE2
Brief Summary
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 adolesc...
Eligibility Criteria
Inclusion
- Males and females aged 12 - 18 years of age;
- DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) diagnosis of TS as assessed by the study clinician;
- TS severity defined as a score of 20 or higher on the Total Tic Severity section of the Yale Global Tic Severity Scale;
- No changes in either medication or other interventions in the 4 weeks prior to randomization, and intention to remain on same dose for the duration of the study;
- Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator;
- Agrees not to drive for the duration of the study.
Exclusion
- Non-English speaking parents;
- Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a family history of psychosis;
- Taking anti-epileptic medications which interact with medicinal cannabis: clobazam, mTOR (mammalian target of rapamycin) inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram \>20mg/day, escitalopram \>10mg/day;
- Abnormal liver function tests defined as ALT (alanine transaminase) \> twice ULN (upper limit of normal);
- Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening;
- Pregnant or intending to become pregnant during the study, or breastfeeding;
- History of clinically significant suicidal thoughts in the prior 12 months.
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05184478
Start Date
May 16 2022
End Date
January 4 2024
Last Update
November 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Children's Hospital / Murdoch Children's Research Institute
Parkville, Victoria, Australia, 3052