Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
|ClinicalTrials.gov Identifier: NCT03066193|
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tourette Syndrome||Drug: Dronabinol Dietary Supplement: Palmotoyletahnolamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Participants will receive two active medications and will be followed-up bi-weekly for 12 weeks.|
|Masking:||None (Open Label)|
|Official Title:||Examining the Efficacy of a Therapeutic Combination of Dronabinol (Synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide for Tourette Syndrome|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||June 28, 2018|
|Actual Study Completion Date :||June 28, 2018|
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. Participants will be receiving PEA concomitantly.
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.
All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol.
Dietary Supplement: Palmotoyletahnolamide
Participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks.
- Improvement in Tic Severity [ Time Frame: 12 weeks ]Yale Global Tic Severity Scale (YGTSS) (Total Tic Score)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066193
|United States, Connecticut|
|Yale Child Study Center|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Michael H. Bloch, MD, MS||Yale University|