Verified February 2017 by Yale University
Sponsor:
Collaborator:
Therapix Biosciences Ltd.
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT03066193
First received: February 23, 2017
Last updated: February 23, 2017
Last verified: February 2017
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.
| Tourette Syndrome | Drug: Dronabinol and Palmotoyletahnolamide | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Intervention Model Description: Participants will receive active medications and will be followed-up bi-weekly for 12 weeks. Masking: No masking |
| Official Title: | Examining the Efficacy of a Therapeutic Combination of Dronabinol (Synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide for Tourette Syndrome |
| Estimated Enrollment: | 18 |
| Actual Study Start Date: | February 1, 2017 |
| Estimated Study Completion Date: | January 2019 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Experimental: Dronabinol and Palmitoylethanolamide
Subjects 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. Subjects will be assigned to receive two 400mg tablets of PEA daily for all 12 weeks. |
Drug: Dronabinol and Palmotoyletahnolamide
Subjects will receive Dronabinol which will be slowly titrated in the first week of the study and will receive the PEA a standing dose of 400mg of PEA. They will be followed for a total of 12 weeks. Other Names:
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We propose a 12-week, investigator-initiated, open-label trial of a therapeutic combination of Dronabinol and PEA in 18 adults with Tourette syndrome. Subjects will receive Dronabinol and PEA in combination for the duration of the trial. Our 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).
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT03066193
| Yale Child Study Center | |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Angeli Landeros, MD 203-737-4809 angeli.landeros@nullyale.edu | |
Yale University
Therapix Biosciences Ltd.
| Principal Investigator: | Michael H. Bloch, MD, MS | Yale University |
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT03066193 History of Changes |
| Other Study ID Numbers: | 1610018525 |
| Study First Received: | February 23, 2017 |
| Last Updated: | February 23, 2017 |
| Individual Participant Data | |
| 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 Cannabinoids Dronabinol |
PEA Palmitoylethanolamide Tourettes TS |
Additional relevant MeSH terms:
| Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Syndrome Tourette Syndrome Disease 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 Palmidrol Dronabinol Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Antiviral Agents Anti-Infective Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on February 28, 2017