Phase I Pilot study of Medicinal Cannabis (MC) in adolescents with Tourette Syndrome (TS).
A Phase 1 Pilot open-label trial of Medicinal Cannabis (MC) in adolescents with Tourette Syndrome (TS)
South Western Sydney Local Health District
10 participants
Sep 9, 2022
Interventional
Conditions
Summary
This is an open labeled pilot study of 10 participants that will be treated with medicinal cannabis (THC: CBD 10:15 oil) in reducing tics-related symptoms in adolescents aged 12 - 18 years with Tourette Syndrome. Eligible participants will receive THC:CBD 10:15 oil. This pilot study will assess the feasibility of conducting a large scale, study of the administration of MC (THC:CBD 10:15 oil) in adolescents with TS. This pilot study will also assess the safety and tolerance of the administration of THC:CBD 10:15 oil in adolescents with TS. Clinician and parent symptom ratings will be compared across the conditions to explore for a signal of efficacy.
Eligibility
Inclusion Criteria6
- Males and females aged 12 – 18 years of age;
- DSM-5 diagnosis of TS as assessed by the study clinician.
- TS severity defined as a score of 20 out of 50 or higher on the Total Tic Severity section of the YGTSS;
- No changes in either medication or other interventions in the 4 weeks prior to enrolment, and intention to remain on the 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 Criteria7
- 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 (e.g. clobazam, topiramate, zonisamide);
- Abnormal liver function tests defined as ALT > twice ULN;
- 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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Interventions
This is an open-label pilot study of 10 participants (adolescents aged 12 to 18 years with TS) who will be treated with Medicinal Cannabis (CBD 15mg/ml, THC 10mg/Ml). Eligible participants will receive THC:CBD 10:15 oil in the Treatment period. Participants weighing <50kg will receive a maximum THC dose of 10mg per day, and those weighing greater than or equal to 50 kg will receive a maximum THC dose of 20mg per day. Both schedules commence with 1mg/day, followed by an initial up-titration period of 21 days. For the lower weight schedule, the dose is increased by 1mg every 4-5 days until they reach 5mg/day. For the higher weight schedule, the dose is increased by 1mg every 2-3 days until they reach 10mg/day. Once participants have been on this dose for 7 days (i.e. Day 29), they will undergo a dose assessment using the Parent Tic Questionnaire, to determine whether they have responded to this dose. Participants will return all study medication (including opened, unopened and empty bottles) at the end of treatment visit for each phase for compliance checking. The remaining volume of each bottle of study medication will be measured and recorded by the study coordinator and cross-checked with the prescribed volume in order to assess participant compliance. Liver function tests will be done at screening and then repeated at the end of treatment period (Day 85). Urine test will be done at screening for illicit drugs and medicinal cannabis. For women of child bearing potential, a pregnancy test will also be conducted at screening and on Day 85.
Locations(1)
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ACTRN12622000031763