Trial Outcomes & Findings for Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome (NCT NCT03066193)
NCT ID: NCT03066193
Last Updated: 2020-02-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-02-24
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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17
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
Baseline characteristics by cohort
| Measure |
Dronabinol and Palmitoylethanolamide
n=16 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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16 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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35 years
n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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15 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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16 participants
n=5 Participants
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Yale Global Severity Scale (YGTSS)Tic total score at baseline
|
38.1 units on a scale
n=5 Participants
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PRIMARY outcome
Timeframe: 12 weeksYale 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.
Outcome measures
| Measure |
Dronabinol and Palmitoylethanolamide
n=16 Participants
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: 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.
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|---|---|
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Changes in Tic Severity
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7.6 score on a scale
Interval 2.5 to 12.8
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Adverse Events
Dronabinol and Palmitoylethanolamide
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dronabinol and Palmitoylethanolamide
n=16 participants at risk
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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|---|---|
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Nervous system disorders
Fatigue/Drowsiness
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100.0%
16/16 • Number of events 16 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
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Nervous system disorders
Feeling "high"
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100.0%
16/16 • Number of events 16 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
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Skin and subcutaneous tissue disorders
Dry Mouth
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93.8%
15/16 • Number of events 15 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
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Nervous system disorders
Dizziness/Lightneadedness
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81.2%
13/16 • Number of events 13 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
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Nervous system disorders
Difficulty concentrating
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81.2%
13/16 • Number of events 13 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
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Nervous system disorders
Headache
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68.8%
11/16 • Number of events 11 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Psychiatric disorders
Anxiety
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68.8%
11/16 • Number of events 11 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Nervous system disorders
Weakness, unsteadiness
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68.8%
11/16 • Number of events 11 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Nervous system disorders
Warmth or tingly feeling
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62.5%
10/16 • Number of events 10 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Nervous system disorders
Gaps in memory
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62.5%
10/16 • Number of events 10 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
|
Nervous system disorders
Ataxia
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62.5%
10/16 • Number of events 10 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Nervous system disorders
Clumsiness
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56.2%
9/16 • Number of events 9 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Nervous system disorders
Lack of coordination
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56.2%
9/16 • Number of events 9 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Nervous system disorders
Depersonalization
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56.2%
9/16 • Number of events 9 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
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Metabolism and nutrition disorders
Increased apetite
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50.0%
8/16 • Number of events 8 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Gastrointestinal disorders
Nausea
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50.0%
8/16 • Number of events 8 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Psychiatric disorders
Exagerated sense or well being
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43.8%
7/16 • Number of events 7 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Eye disorders
Red eyes
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43.8%
7/16 • Number of events 7 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Nervous system disorders
Heavy limbs/muscles
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43.8%
7/16 • Number of events 7 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Psychiatric disorders
Sleep problems (insomnia)
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37.5%
6/16 • Number of events 6 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Eye disorders
Blurry vision
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37.5%
6/16 • Number of events 6 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Metabolism and nutrition disorders
Decrease in apetite
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37.5%
6/16 • Number of events 6 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Psychiatric disorders
Paranoia
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37.5%
6/16 • Number of events 6 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Psychiatric disorders
Mood changes
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31.2%
5/16 • Number of events 5 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Musculoskeletal and connective tissue disorders
Muscle aches/pains
|
31.2%
5/16 • Number of events 5 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Gastrointestinal disorders
Stomach pain
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25.0%
4/16 • Number of events 4 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Gastrointestinal disorders
Diarrhea
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25.0%
4/16 • Number of events 4 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
|
Psychiatric disorders
Panic attack
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25.0%
4/16 • Number of events 4 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
|
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Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • Collected at each study visit. Participants would come in every two weeks for twelve weeks.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place