Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03066193 | Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome | PHASE2 | COMPLETED | 17 | — | — | Feb 1, 2017 | Jun 28, 2018 | Feb 24, 2020 | 1 | United States |
Yale Global Tic Severity Scale (YGTSS) (Total Tic Score) The YGTSS tool gives ratings in 5 domains: Total Motor Tic Score, Total Verbal Tic Score, Total Tic Score (Motor + Verbal), Overall Impairment Rating, and Global Severity Score. When calculating the Global Severity score, it is found by adding together the total motor, verbal and impairment scores. The Total Tic Severity Score has a range of 0-50, and the Global Severity Score has a range of 0- 100. A higher score on all scales suggests a more severe Tic, or a greater impact the Tic has on the person's life.
| Arm | Type | Description |
|---|---|---|
| Dronabinol and Palmitoylethanolamide | EXPERIMENTAL | All participants will be titrated up on Dronabinol dose during the first week of the trial (2.5mg Dronabinol for 3 days and then 5mg Dronabinol for 4 days increasing to 10mg Dronabinol for the remainder of the trial). Dronabinol will only be increased to 10mg at the week 1 assessment if the subject is tolerating the 5mg dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol. |
| Name | Type | Description |
|---|---|---|
| Dronabinol and Palmitoylethanolamide | DRUG | Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks; in addition, participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks. |
Inclusion Criteria: * Adult between 18-60 years of age * Meet DSM-5 criteria for the diagnosis of Tourette syndrome * Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at baseline * On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginnin...