Tourette SyndromePhase 2NCT03066193
Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
A Phase 2 study testing Dronabinol and Palmitoylethanolamide in people with Tourette Syndrome, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Dronabinol and Palmitoylethanolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 28 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06520
About this study
Official title: 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.
Read the 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).
- Conditions
- Tourette Syndrome
- Being tested
- Dronabinol and Palmitoylethanolamide
- Keywords
- Motor tics, Vocal tics, Cannabinoids, Dronabinol, PEA, Palmitoylethanolamide, Tourettes, TS
- Medical subject headings
- Tourette Syndrome, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol and PalmitoylethanolamideDrug
Also called synthetic Δ9THC, Marinol, C21H30O2, Δ9-Tetrahydracannabinol
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dronabinol and Palmitoylethanolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Feb 2017
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive two active medications and will be followed-up bi-weekly for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Neurothera Labs Inc.
- Responsible party
- Sponsor
- Investigators
- Michael H. Bloch, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066193
- Sponsor's protocol ID
- 1610018525
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2017
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of a Therapeutic Combination of Dronabinol (Synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide for Tourette Syndrome
- ClinicalTrials.gov ID
- NCT03066193
- Acronym / sponsor ID
- 1610018525
- Conditions
- Tourette Syndrome
- Keywords
- Motor tics, Vocal tics, Cannabinoids, Dronabinol, PEA, Palmitoylethanolamide, Tourettes, TS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Neurothera Labs Inc.
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Posted 19 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive two active medications and will be followed-up bi-weekly for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Dronabinol and Palmitoylethanolamide | Experimental | Drug: Dronabinol and PalmitoylethanolamideAll 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronabinol and PalmitoylethanolamideAlso: synthetic Δ9THC, Marinol, C21H30O2, Δ9-TetrahydracannabinolParticipants 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. | Drug | Dronabinol and Palmitoylethanolamide |
Primary outcome
Changes in Tic Severity
Time frame: 12 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H. Bloch, MD, MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dronabinol and Palmitoylethanolamide in people with Tourette Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Tic Severity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.