Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as synthetic Δ9THC, Marinol, C21H30O2, Δ9-Tetrahydracannabinol, PEA, C18H37NO2, PeaPure, N-palmitoylethanolamine
Dronabinol and Palmitoylethanolamide · 1 trial · 1 indication
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...
Dronabinol and palmitoylethanolamide is an investigational drug combination being studied for Tourette Syndrome. It pairs dronabinol, a cannabinoid, with palmitoylethanolamide, a fatty acid amide. SciSparc Ltd. is developing it as a small molecule therapy in the neurology therapeutic area.
Dronabinol and palmitoylethanolamide targets CNR1, the cannabinoid receptor type 1. The drug acts as an agonist at this receptor. CNR1 is a G protein-coupled receptor that is part of the endocannabinoid system and is expressed in the central nervous system.
SciSparc Ltd. is developing dronabinol and palmitoylethanolamide. SciSparc trades on the Nasdaq under the ticker SPRC. The company is advancing the combination as a small molecule candidate for Tourette Syndrome.
Dronabinol and palmitoylethanolamide is in Phase 2 clinical development. It is an investigational drug combination and has not been approved by the FDA. SciSparc Ltd. has completed one Phase 2 trial of the combination in Tourette Syndrome.
Dronabinol and palmitoylethanolamide has been studied in one Phase 2 trial, NCT03066193, titled Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome. The trial is completed and enrolled 17 participants in the United States. It was an uncontrolled study in adults aged 18 years and older.