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| Name | Class |
|---|---|
| Neurothera Labs Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael H. Bloch, MD, MS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Child Study Center | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dronabinol and Palmitoylethanolamide | 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 received two 400mg tablets of PEA daily for the same 12 weeks that they received the Dronabinol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dronabinol and Palmitoylethanolamide | 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. All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol. 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. Palmotoyletahnolamide: Participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
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Collected at each study visit. Participants would come in every two weeks for twelve weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dronabinol and Palmitoylethanolamide | 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. Dronabinol and Palmitoylethanolamide: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue/Drowsiness | Nervous system disorders | AERS | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael H. Bloch | Yale University | 2037374539 | michael.bloch@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2017 | Oct 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| D020323 | Tics |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| C005958 | palmidrol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Participants will receive two active medications and will be followed-up bi-weekly for 12 weeks.
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|
|
| Participants |
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| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Yale Global Severity Scale (YGTSS)Tic total score at baseline | 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 | Mean | Full Range | units on a scale |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 16 |
| 16 |
| Feeling "high" | Nervous system disorders | AERS | Systematic Assessment |
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| Dry Mouth | Skin and subcutaneous tissue disorders | AERS | Systematic Assessment |
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| Dizziness/Lightneadedness | Nervous system disorders | AERS | Systematic Assessment |
|
| Difficulty concentrating | Nervous system disorders | AERS | Systematic Assessment |
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| Headache | Nervous system disorders | AERS | Systematic Assessment |
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| Anxiety | Psychiatric disorders | AERS | Systematic Assessment |
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| Weakness, unsteadiness | Nervous system disorders | AERS | Systematic Assessment |
|
| Warmth or tingly feeling | Nervous system disorders | AERS | Systematic Assessment |
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| Gaps in memory | Nervous system disorders | AERS | Systematic Assessment |
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| Ataxia | Nervous system disorders | AERS | Systematic Assessment |
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| Clumsiness | Nervous system disorders | AERS | Systematic Assessment |
|
| Lack of coordination | Nervous system disorders | AERS | Systematic Assessment |
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| Depersonalization | Nervous system disorders | AERS | Systematic Assessment |
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| Increased apetite | Metabolism and nutrition disorders | AERS | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | AERS | Systematic Assessment |
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| Exagerated sense or well being | Psychiatric disorders | AERS | Systematic Assessment |
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| Red eyes | Eye disorders | AERS | Systematic Assessment |
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| Heavy limbs/muscles | Nervous system disorders | AERS | Systematic Assessment |
|
| Sleep problems (insomnia) | Psychiatric disorders | AERS | Systematic Assessment |
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| Blurry vision | Eye disorders | AERS | Systematic Assessment |
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| Decrease in apetite | Metabolism and nutrition disorders | AERS | Systematic Assessment |
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| Paranoia | Psychiatric disorders | AERS | Systematic Assessment |
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| Mood changes | Psychiatric disorders | AERS | Systematic Assessment |
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| Muscle aches/pains | Musculoskeletal and connective tissue disorders | AERS | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | AERS | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | AERS | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | AERS | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | AERS | Systematic Assessment |
|
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| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |