Phase I Pilot study of Medicinal Cannabis (MC) in adolescents with Tourette Syndrome (TS).

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.