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

NCT03066193 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1610018525
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome

Keywords

Motor tics; Vocal tics; Cannabinoids; Dronabinol; PEA; Palmitoylethanolamide; Tourettes; TS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Dronabinol and Palmitoylethanolamide

EXPERIMENTAL

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. All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol.

Drug: Dronabinol and Palmitoylethanolamide

Interventions

Dronabinol and Palmitoylethanolamide DRUG

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.

Also known as: synthetic Δ9THC, Marinol, C21H30O2, Δ9-Tetrahydracannabinol, PEA, C18H37NO2, PeaPure, N-palmitoylethanolamine, MimyX, Impulsin, Normast

Dronabinol and Palmitoylethanolamide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• SciSparc: collaborator

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tics

Interventions

Dronabinol; palmidrol

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Michael H. Bloch
• Organization: Yale University

michael.bloch@yale.edu

2037374539

Study Officials

• Michael H. Bloch, MD, MS

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive two active medications and will be followed-up bi-weekly for 12 weeks.

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: February 1, 2017
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: February 24, 2020
• Results First Posted: December 19, 2019

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)