Approval Probability
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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 small molecule combination being studied for the treatment of Tourette Syndrome, a neurological condition characterized by involuntary movements and vocalizations called tics. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Dronabinol and Palmitoylethanolamide is being developed by SciSparc Ltd., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SPRC. The company is conducting clinical research to evaluate this combination therapy for Tourette Syndrome.
Dronabinol and Palmitoylethanolamide is in Phase 2 clinical development for Tourette Syndrome. It remains investigational and has not received FDA approval. A Phase 2 clinical trial has been completed, and the drug is still undergoing clinical evaluation.
Dronabinol and Palmitoylethanolamide has one completed Phase 2 clinical trial, NCT03066193, titled 'Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome.' This uncontrolled study enrolled 17 participants in the United States, with a minimum age of 18 years.
Dronabinol and Palmitoylethanolamide is a combination therapy that includes palmitoylethanolamide (PEA) as one of its components. The drug combines dronabinol with PEA, and the clinical trial NCT03066193 refers to this combination as 'Dronabinol and PEA.'