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. Identifier: NCT03066193
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : March 3, 2017
Therapix Biosciences Ltd.
Information provided by (Responsible Party):
Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Tourette Syndrome Drug: Dronabinol Dietary Supplement: Palmotoyletahnolamide Phase 3

Detailed 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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: Dronabinol
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.
Drug: Dronabinol
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.
Other Names:
  • synthetic Δ9THC
  • Marinol
  • C21H30O2
  • Δ9-Tetrahydracannabinol

Experimental: Palmitoylethanolamide
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.
Other Names:
  • Normast
  • Impulsin
  • MimyX
  • N-palmitoylethanolamine
  • PeaPure
  • C18H37NO2
  • PEA

Primary Outcome Measures :
  1. Improvement in Tic Severity [ Time Frame: 12 weeks ]
    Yale Global Tic Severity Scale (YGTSS) (Total Tic Score)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03066193

Contact: Angeli Landeros, MD 203-737-4809
Contact: Jessica Johnson, BS 203-737-4809

United States, Connecticut
Yale Child Study Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Angeli Landeros, MD    203-737-4809   
Sponsors and Collaborators
Yale University
Therapix Biosciences Ltd.
Principal Investigator: Michael H. Bloch, MD, MS Yale University

Responsible Party: Yale University Identifier: NCT03066193     History of Changes
Other Study ID Numbers: 1610018525
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
Motor tics
Vocal tics

Additional relevant MeSH terms:
Tourette Syndrome
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists