An observational study in Tourette Syndrome and Cannabis, sponsored by Tel-Aviv Sourasky Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-11-10.
Sponsored by Tel-Aviv Sourasky Medical Center · Observational
Medical cannabis (MC) is a standard treatment in Israel to adults with resistant Gilles de la Tourette syndrome (GTS). While small randomized control trials assessed THC efficacy on tics and premonitory urge, only small retrospective studies assessed MC efficacy and tolerability in GTS. Herein, By using an open-label, prospective design, our aim is to determine the preferred method of use, efficacy and tolerability of 12 weeks of treatment with MC in adult patients with GTS.
Gilles de la Tourette syndrome (GTS) is a childhood onset neuropsychiatric disorder characterized by the presence of multiple motor and one or more phonic tics continuing for at least one year. In Israel, although consumption of cannabis is outlawed, there is an option to allow patients to consume the drug under supervision. Medical Cannabis (MC) consumed by inhalation of smoked or vaporized dried female buds, or subligual oil extract of whole plant, has been an approved treatment by the Ministry of Health (MOH) for resistant GTS since 2013. Previous studies suggested that MC has a good effect on tics, quality of like and with good tolerability among patients with resistant GTS.
In the current study, we prospectively followed-up patients eligible for MC according to MOH restrictions, at our GTS clinic at the Tel-Aviv Sourasky Movement Disorders Unit (MDU). Each subject signed a written informed consent before inclusion in the trial. Also, since driving under the influence of cannabis is forbidden by the Israeli law, patients were instructed and gave their oral commitment to avoid driving. The study was approved by the research ethics (Helsinki) committee at our center. MC was consumed as oil extract, vaporized, or smoked dried buds. The treating neurologist (S.A.) and patient together decided on the method of consumption during the visit before initiating treatment. Patients were assessed 4 and 12-weeks following treatment initiation to gather data regarding treatment efficacy, tolerability and SEs.
220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 43 observational studies indexed under Tourette Syndrome.
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Adult patients with resistant Tourette syndrome
Exclusion Criteria:
Patients will be assessed before (baseline), 4 (visit 2) and 12 weeks (visit 3) after use of Medical cannabis via inhaled dried buds or sublingual oil extract. The percentage of THC and CBD were pre-set to 10% and 2%, respectively. All patients received the same general instructions for treatment titration, which was to start with 1 drop or puff a day and increase by 1 drop or puff as needed. There was no fixed schedule for the incremental increases, thus each patient freely raised the dose as well as number of daily consumptions until clinical benefit was achieved or SE emerged over a follow-up period of 12 weeks.
Drug: Medical Cannabis
Patients with GTS were assessed before, 4 and 12 weeks after Medical cannabis initiation for consumption habits, efficacy and side effect profile
Change in vocal and motor tics and disease burden
Using Yale Global Tic Severity Scale (YGTSS), range 0-100, higher scores mean a worse outcome
Time frame: Baseline, after 4 and 12 weeks since treatment initiation
Change in premonitory urge
using Premonitory Urge for Tic Scale (PUTS), range 0-36, higher scores mean a worse outcome
Time frame: Baseline, after 4 and 12 weeks since treatment initiation
Subjective improvement of tics and Quality of life
Using a 7-point Likert-type scale, range 1-7, higher scores mean a better outcome
Time frame: Baseline, after 4 and 12 weeks since treatment initiation
Examine patient's tetrahydrocannabinol-9-delta (THC) and Cannabidiol (CBD) consumption per month
Measuring total THC and CBD consumption per month in grams
Time frame: After 12 weeks since treatment initiation
Assessment of major side effects of treatment
report (yes/no) on side effects from list and (free text) to add notes on side effect. List: Anxiety, Cognitive, Dizziness, Sedation, Fatigue, Red eyes , Dry mouth, Gastrointestinal
Time frame: After 4 and 12 weeks since treatment initiation
Plan to share: No
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Tel-Aviv Sourasky Medical Center