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

  • STATUS
    Recruiting
  • End date
    Jun 6, 2023
  • participants needed
    10
  • sponsor
    Murdoch Childrens Research Institute
Updated on 6 June 2022

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 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.

Details
Condition Tourette Syndrome in Adolescence
Treatment Placebo, Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd.
Clinical Study IdentifierNCT05184478
SponsorMurdoch Childrens Research Institute
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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