Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Examining the Efficacy of a Therapeutic Combination of Dronabinol (Synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide for Tourette Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066193
• Other study ID #: 1610018525
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2017
• Est. completion date: June 28, 2018

Study information

• Verified date: February 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an investigator-initiated proof of concept study with the purpose to examine the safety, tolerability and feasibility of Dronabinol (synthetic Δ9-THC) and PEA for the treatment of adults with Tourette syndrome.

Description:

The investigators propose a 12-week, investigator-initiated, open-label trial of a therapeutic combination of Dronabinol and PEA in 18 adults with Tourette syndrome. Participants will receive Dronabinol and PEA in combination for the duration of the trial. The goal for this pilot study is to (1) provide initial safety, feasibility and tolerability data on both Dronabinol and PEA in a TS population and (2) provide data in order to make a more informed decision regarding the appropriate sample size and design of a larger clinical trial to prove efficacy (i.e. sample size and trial duration in large efficacy trial of the Dronabinol/PEA combination in TS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 beginning the trial

• Accepted method of birth control

Exclusion Criteria:

• Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70)

• Recent change (less than 4 weeks) in other medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). Medication change is defined to include dose changes or medication discontinuation.

• Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.

• Taking any co-medications (over the counter or prescription), food supplements/additives which can have a drug interaction with dronabinol or PEA.

• Positive pregnancy test or drug screening test

• History of cannabis dependence

• Significant Medical Comorbidity

• History of hypersensitivity to any cannabinoid or sesame oil

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Drug:
• Dronabinol and Palmitoylethanolamide
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.

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Therapix Biosciences Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Tic Severity	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.	12 weeks