Is Medicinal Cannabis an Effective Treatment for Tourette Syndrome in Adolescents? a Pilot Study

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 16, 2022

Primary Completion Date

December 5, 2023

Study Completion Date

January 4, 2024

Conditions
Tourette Syndrome in Adolescence
Interventions
DRUG

Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd.

"Each 1mL contains 10mg tetrahydrocannabinol (THC),15 mg cannabidiol (CBD), and 0.004mL peppermint oil in medium chain triglyceride (MCT) oil.~All participants will start at 0.1 mL per day, and will gradually increase in 0.1mL increments until day 21 when a dose of 0.5mL (participants weighing \<50kg) or 1mL (participants weighing ≥50kg) is reached. At day 29, an assessment of treatment response will be conducted. Participants who meet criteria for a treatment response will remain on the same dose for the remainder of the treatment period. Participants who do not meet criteria for a treatment response will gradually increase the dose in 0.1mL increments until day 49 when a daily dose of 1mL (participants weighing \<50kg) or 2mL (participants ≥50kg) is reached."

DRUG

Placebo

"The placebo contains MCT oil and peppermint flavoring solution, which is indistinguishable from the active medication in appearance, smell and taste.~The dose will be matched for volume to the medicinal cannabis, and will follow the same dosing schedule as the medicinal cannabis treatment phase."

Trial Locations (1)

3052

Royal Children's Hospital / Murdoch Children's Research Institute, Parkville

All Listed Sponsors
lead

Murdoch Childrens Research Institute

OTHER