The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome

• ClinicalTrials.gov Identifier: NCT05115318
• Recruitment Status: Completed
• First Posted: November 10, 2021
• Last Update Posted: November 10, 2021
• Sponsor: Tel-Aviv Sourasky Medical Center
• Information provided by (Responsible Party): Tel-Aviv Sourasky Medical Center

Tracking Information

• First Submitted Date: October 16, 2021
• First Posted Date: November 10, 2021
• Last Update Posted Date: November 10, 2021
• Actual Study Start Date: July 1, 2020
• Actual Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 29, 2021)

• Change in vocal and motor tics and disease burden [ Time Frame: Baseline, after 4 and 12 weeks since treatment initiation ]
  Using Yale Global Tic Severity Scale (YGTSS), range 0-100, higher scores mean a worse outcome
• Change in premonitory urge [ Time Frame: Baseline, after 4 and 12 weeks since treatment initiation ]
  using Premonitory Urge for Tic Scale (PUTS), range 0-36, higher scores mean a worse outcome
• Subjective improvement of tics and Quality of life [ Time Frame: Baseline, after 4 and 12 weeks since treatment initiation ]
  Using a 7-point Likert-type scale, range 1-7, higher scores mean a better outcome

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 29, 2021)

• Examine patient's tetrahydrocannabinol-9-delta (THC) and Cannabidiol (CBD) consumption per month [ Time Frame: After 12 weeks since treatment initiation ]
  Measuring total THC and CBD consumption per month in grams
• Assessment of major side effects of treatment [ Time Frame: After 4 and 12 weeks since treatment initiation ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome
• Official Title: The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adult patients with resistant Tourette syndrome

Condition

• Tourette Syndrome
• Cannabis

Intervention

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

Study Groups/Cohorts

Adult Tourette syndrome patients

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.

Intervention: Drug: Medical Cannabis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 29, 2021): 18
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 31, 2021
• Actual Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age 18 - 65 years
• Diagnosis of GTS confirmed by the treating neurologist based on the DSM-V criteria
• Eligibility to receive MOH MC license for GTS
• Provided written informed consent

Exclusion Criteria:

• Regularly use cannabis in any form for self-medication prior to entering the study
• Pregnant or lactating women
• Have a tic disorder other than GTS
• Have concurrent physical or mental disease that could interfere with the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT05115318
• Other Study ID Numbers: 0491-10-TLV
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Tel-Aviv Sourasky Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Tel-Aviv Sourasky Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Tel-Aviv Sourasky Medical Center
• Verification Date: October 2021