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

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

February 23, 2017
February 28, 2017
March 3, 2017
February 1, 2017
January 2018   (Final data collection date for primary outcome measure)
Improvement in Tic Severity [ Time Frame: 12 weeks ]
Yale Global Tic Severity Scale (YGTSS) (Total Tic Score)
Same as current
Complete list of historical versions of study NCT03066193 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
Examining the Efficacy of a Therapeutic Combination of Dronabinol (Synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide for Tourette Syndrome
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.
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).
Interventional
Phase 3
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
Tourette Syndrome
  • 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
  • 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
  • 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.
    Intervention: Drug: Dronabinol
  • Experimental: Palmitoylethanolamide
    All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol.
    Intervention: Dietary Supplement: Palmotoyletahnolamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
Same as current
January 2019
January 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact: Angeli Landeros, MD 203-737-4809 angeli.landeros@yale.edu
Contact: Jessica Johnson, BS 203-737-4809 jessica.johnson@yale.edu
United States
 
 
NCT03066193
1610018525
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Yale University
Yale University
Therapix Biosciences Ltd.
Principal Investigator: Michael H. Bloch, MD, MS Yale University
Yale University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP