Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03066193|
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tourette Syndrome||Drug: Dronabinol Dietary Supplement: Palmotoyletahnolamide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 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|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2019|
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
|Contact: Angeli Landeros, MDemail@example.com|
|Contact: Jessica Johnson, BSfirstname.lastname@example.org|
|United States, Connecticut|
|Yale Child Study Center||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Angeli Landeros, MD 203-737-4809 email@example.com|
|Principal Investigator:||Michael H. Bloch, MD, MS||Yale University|