Tourette Syndrome in AdolescencePhase 1/2NCT05184478

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

A Phase 1/2 study testing Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd. in people with Tourette Syndrome in Adolescence, run by Murdoch Childrens Research Institute at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 12 to 18 years
Conditions the study is for: Tourette Syndrome in Adolescence
What is being tested?: Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd.
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteAustralia
Study dates: 16 May 2022to 4 Jan 2024
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Royal Children's Hospital / Murdoch Children's Research Institute
Parkville, Victoria, 3052

Other trials in Australia

About this study

Official title: A Pilot Randomized Placebo-controlled Crossover Trial of Medicinal Cannabis (MC) in Adolescents with 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.

Conditions: Tourette Syndrome in Adolescence
Being tested: Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd., Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05184478
Study group	Role	What they receive
Group A (MC then placebo)	Experimental	Group A will receive medicinal cannabis during Treatment Period 1 (70 days), followed by a 7 day dose reduction and 21 day wash-out period, then will receive placebo during Treatment Period 2 (70 days). Receives: Drug: Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd.; Drug: Placebo
Group B (placebo then MC)	Experimental	Group B will receive placebo during Treatment Period 1 (70 days), followed by a 7 day dose reduction and 21 day wash-out period, then will receive medicinal cannabis during Treatment Period 2 (70 days). Receives: Drug: Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd.; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of study participant recruitment, calculated as the time required to reach a sample size of 10.
The rate of recruitment will be calculated as the number of months from the date of commencing recruitment to the date of randomizing the tenth participant.
Measured: From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.
Participant withdrawal rate, calculated as the number of participants who withdraw from the trial as a proportion of the total number of participants randomized.
The number of participants who withdraw from the trial will be calculated as a proportion of the total number of participants randomized.
Measured: Day 1 to day 176 (end of treatment period 2)
Study medication tolerability, as indicated by the proportion of participants who tolerate the protocol dosing schedule.
The number of participants who adhere to the protocol dosing schedule without medication related protocol deviations, treatment discontinuations or dose modifications will be calculated as a proportion of the total sample for each treatment condition (medicinal cannabis or placebo).
Measured: Day 1 to day 176 (end of treatment period 2)
Participant adherence to the study medication dosing schedule, calculated as the proportion of participants who demonstrate acceptable medication compliance.
Medication compliance will be assessed through pharmacy calculations from returned bottle volumes. Acceptable compliance will fall within the range of 80-120%. The number of participants with acceptable medication compliance will be reported as a proportion of the total sample randomized.
Measured: Day 78 (end of treatment period 1) and day 176 (end of treatment period 2)
Study visit attendance, calculated as the proportion of visits completed across the study sample.
The number of study visits attended by all participants will be calculated as a proportion of the total possible visits in accordance with the study protocol.
Measured: Screening to day 169 (final study visit)
Blood test completion, calculated as the proportion of blood tests completed across the study sample.
The number of study blood tests completed by all participants will be calculated as a proportion of the total possible blood tests in accordance with the study protocol.
Measured: Screening to day 169 (final study visit)
Parent questionnaire completion, calculated as the proportion of parent-report questionnaires completed across the study sample.
The number of study questionnaires completed by all parents will be calculated as a proportion of the total possible questionnaires requiring completion in accordance with the study protocol.
Measured: Screening to day 169 (final study visit)
Self-report questionnaire completion, calculated as the proportion of adolescent self-report questionnaires completed across the study sample.
The number of study self-report questionnaires completed by all participants will be calculated as a proportion of the total possible questionnaires requiring completion in accordance with the study protocol.
Measured: Screening to day 169 (final study visit)
Study design acceptability will be evaluated through a parent-completed study specific evaluation questionnaire completed at the end of the study.
Study design acceptability will be assessed using an evaluation questionnaire developed specifically for this study, which uses Likert scales to assess satisfaction with recruitment, medication tolerability, frequency of study visits, burden of completing questionnaires, and overall study quality. Parents will complete this questionnaire at the end of their study participation (day 197). Data will be reported for each item individually, as the proportion of parents who responded positively on the Likert scale, where higher scores indicate more favorable responses.
Measured: Day 197

Secondary outcomes (2)

The frequency of adverse events as reported on the modified version of the Liverpool Adverse Event Profile (LAEP) at day 71 and day 169 will be summarized across the medicinal cannabis and placebo treatment phases.
Completed by the parent or guardian, the LAEP was designed to capture known side-effects of anti-epileptic medication. The modified version includes additional items to ascertain other known side-effects of medicinal cannabis. This measure includes 34 items. Adverse Events (AEs) reported on the LAEP will be considered significant if a 2-point increase in severity is reported from baseline to end of the maintenance dosing period (day 71 and day 176). The frequency of AEs meeting this criteria will be presented for the medicinal cannabis and placebo treatment phases respectively.
Measured: Day 71 and 176
The frequency of adverse events as reported throughout the study will be summarized across the medicinal cannabis and placebo treatment phases.
All possible adverse events will be recorded, as reported at study visits, during safety check phone calls and in between scheduled appointments. All Serious Adverse Events will be published, as well as all non-serious adverse events deemed by the investigators to be at least possibly related to the study drug. The frequency of these adverse events will be presented for the medicinal cannabis and placebo treatment phases respectively.
Measured: Day 1 to day 197

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 20224 Jan 2024

First posted11 Jan 2022
Study start16 May 2022
Primary completion5 Dec 2023
Study completion4 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tourette Syndrome in AdolescenceStudies of the same condition, open and under way.
More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Eligible participants will be randomized 1:1 to initially receive either THC:CBD 10:15 oil or placebo in Treatment Period 1, before crossing over and receiving the other study drug (THC:CBD 10:15 oil or placebo) in Treatment Period 2.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05184478
Sponsor's protocol ID: RCH HREC 69238
Status last verified: Apr 2024
First submitted: 2 Dec 2021
Last updated: 27 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The de-identified data set collected for this analysis of the MC in TS Pilot Study will be available six months after publication of the primary outcome. The study protocol and analysis plan will also be available. The data must be obtained from the Murdoch Children's Research Institute. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the 'MC in TS Pilot Study' Study Management Group must see and approve the data analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered. Should the Study Management Group be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognized research organisation which has approved the proposed analysis plan.

Publications

Efron D, Taylor K, Chan E, Payne JM, Prakash C, Lee KJ, Cranswick N, Lin PD, Eapen V. A Pilot Randomized Placebo-Controlled Crossover Trial of Medicinal Cannabis in Adolescents with Tourette Syndrome. Cannabis Cannabinoid Res. 2025 Dec;10(6):702-709. doi: 10.1089/can.2024.0188. Epub 2025 Mar 17.
PubMed 40082070

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tourette Syndrome in Adolescence trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Randomized Placebo-controlled Crossover Trial of Medicinal Cannabis (MC) in Adolescents with Tourette Syndrome (TS)
ClinicalTrials.gov ID: NCT05184478
Acronym / sponsor ID: RCH HREC 69238
Conditions: Tourette Syndrome in Adolescence
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Murdoch Childrens Research InstituteUniversity, hospital or other
Study start: 16 May 2022 (actual)
Primary completion: 5 Dec 2023 (actual)
Study completion: 4 Jan 2024 (actual)
First posted: 11 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Eligible participants will be randomized 1:1 to initially receive either THC:CBD 10:15 oil or placebo in Treatment Period 1, before crossing over and receiving the other study drug (THC:CBD 10:15 oil or placebo) in Treatment Period 2.

Arm	Type	Receives
Group A (MC then placebo)	Experimental	Drug: Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd., Drug: PlaceboGroup A will receive medicinal cannabis during Treatment Period 1 (70 days), followed by a 7 day dose reduction and 21 day wash-out period, then will receive placebo during Treatment Period 2 (70 days).
Group B (placebo then MC)	Experimental	Drug: Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd., Drug: PlaceboGroup B will receive placebo during Treatment Period 1 (70 days), followed by a 7 day dose reduction and 21 day wash-out period, then will receive medicinal cannabis during Treatment Period 2 (70 days).

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Group A (MC then placebo), Group B (placebo then MC)
PlaceboThe 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.	Drug	Group A (MC then placebo), Group B (placebo then MC)

Primary outcome

Rate of study participant recruitment, calculated as the time required to reach a sample size of 10.
Time frame: From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.
The rate of recruitment will be calculated as the number of months from the date of commencing recruitment to the date of randomizing the tenth participant.
Participant withdrawal rate, calculated as the number of participants who withdraw from the trial as a proportion of the total number of participants randomized.
Time frame: Day 1 to day 176 (end of treatment period 2)
The number of participants who withdraw from the trial will be calculated as a proportion of the total number of participants randomized.
Study medication tolerability, as indicated by the proportion of participants who tolerate the protocol dosing schedule.
Time frame: Day 1 to day 176 (end of treatment period 2)
The number of participants who adhere to the protocol dosing schedule without medication related protocol deviations, treatment discontinuations or dose modifications will be calculated as a proportion of the total sample for each treatment condition (medicinal cannabis or placebo).
Participant adherence to the study medication dosing schedule, calculated as the proportion of participants who demonstrate acceptable medication compliance.
Time frame: Day 78 (end of treatment period 1) and day 176 (end of treatment period 2)
Medication compliance will be assessed through pharmacy calculations from returned bottle volumes. Acceptable compliance will fall within the range of 80-120%. The number of participants with acceptable medication compliance will be reported as a proportion of the total sample randomized.
Study visit attendance, calculated as the proportion of visits completed across the study sample.
Time frame: Screening to day 169 (final study visit)
The number of study visits attended by all participants will be calculated as a proportion of the total possible visits in accordance with the study protocol.
Blood test completion, calculated as the proportion of blood tests completed across the study sample.
Time frame: Screening to day 169 (final study visit)
The number of study blood tests completed by all participants will be calculated as a proportion of the total possible blood tests in accordance with the study protocol.
Parent questionnaire completion, calculated as the proportion of parent-report questionnaires completed across the study sample.
Time frame: Screening to day 169 (final study visit)
The number of study questionnaires completed by all parents will be calculated as a proportion of the total possible questionnaires requiring completion in accordance with the study protocol.
Self-report questionnaire completion, calculated as the proportion of adolescent self-report questionnaires completed across the study sample.
Time frame: Screening to day 169 (final study visit)
The number of study self-report questionnaires completed by all participants will be calculated as a proportion of the total possible questionnaires requiring completion in accordance with the study protocol.
Study design acceptability will be evaluated through a parent-completed study specific evaluation questionnaire completed at the end of the study.
Time frame: Day 197
Study design acceptability will be assessed using an evaluation questionnaire developed specifically for this study, which uses Likert scales to assess satisfaction with recruitment, medication tolerability, frequency of study visits, burden of completing questionnaires, and overall study quality. Parents will complete this questionnaire at the end of their study participation (day 197). Data will be reported for each item individually, as the proportion of parents who responded positively on the Likert scale, where higher scores indicate more favorable responses.

2 secondary outcomes

The frequency of adverse events as reported on the modified version of the Liverpool Adverse Event Profile (LAEP) at day 71 and day 169 will be summarized across the medicinal cannabis and placebo treatment phases.
Time frame: Day 71 and 176
The frequency of adverse events as reported throughout the study will be summarized across the medicinal cannabis and placebo treatment phases.
Time frame: Day 1 to day 197

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Derived from this study: PubMed 40082070Efron D, Taylor K, Chan E, Payne JM, Prakash C, Lee KJ, Cranswick N, Lin PD, Eapen V. A Pilot Randomized Placebo-Controlled Crossover Trial of Medicinal Cannabis in Adolescents with Tourette Syndrome. Cannabis Cannabinoid Res. 2025 Dec;10(6):702-709. doi: 10.1089/can.2024.0188. Epub 2025 Mar 17.
Individual participant dataSharing planned: Yes. The de-identified data set collected for this analysis of the MC in TS Pilot Study will be available six months after publication of the primary outcome. The study protocol and analysis plan will also be available. The data must be obtained from the Murdoch Children's Research Institute. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the 'MC in TS Pilot Study' Study Management Group must see and approve the data analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered. Should the Study Management Group be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognized research organisation which has approved the proposed analysis plan.

Related trials for Tourette Syndrome in Adolescence

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of study participant recruitment, calculated as the time required to reach a sample size of 10. (time frame: From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05184478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.