Tourette SyndromePhase 2NCT05126888
SCI-110 in the Treatment of Tourette Syndrome
A Phase 2 study testing SCI-110 in people with Tourette Syndrome, run by Neurothera Labs Inc. at 3 sites in 3 countries.
Trial summary
To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- SCI-110
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tourette syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
- Male and female subjects with an age between ≥18 and ≤65 years
- Total tic score (TTS) of the revised Yale Global Tic Severity Scale (YGTSS-R) \>14
- Clinical Global Impression-Severity Score (CGI-S) ≥4
- Medication (and stimulation parameters for deep brain stimulation) for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study and subject must consent to maintain the stable dose during the study
- Signed written informed consent and willingness to comply with treatment and follow-up procedures
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- Subjects capable of understanding the investigational nature, potential risks and benefits of the clinical study
- Women of child-bearing potential must have a negative pregnancy test (e.g., urine human chorionic gonadotropin [hCG]) before first treatment with study medication. They must practice a highly effective, reliable and medically approved contraceptive regimen during the study (e.g., theoretical failure rate less than 1% per year as when used consistently and correctly), which include oral or parenteral or implanted hormonal contraception, vaginal ring releasing hormonal contraception (e.g., Nuvaring), intrauterine device or intrauterine system. Women without childbearing potential may enter this study. Women without childbearing potential defined as follows:
- at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
- hysterectomy or uterine agenesis or
- ≥ 50 years and in postmenopausal state ≥ 1 year or
- \< 50 years and in postmenopausal state ≥ 1 year with urine FSH \> 40 IU/l and urine oestrogen \< 30 ng/l, or serum follicle stimulating hormone (FSH) in the post-menopausal range or a negative oestrogen test.
- Male subjects must be willing to use a condom with sexual partners during this study and for a period of three months following the last administration of study medication until the follow-up visit. Male subjects must be willing to abstain from sperm donation for 3 months after the completion of this study
Who cannot join
- Comorbid obsessive-compulsive disorder (OCD), attention deficit/hyperactivity disorder (ADHD), depression, and anxiety disorder when unstable or in need of an initial adjustment for a therapy-according to the investigator's judgment
- Presence of severe psychiatric conditions such as developmental disability, psychotic illness and bipolar disorder- according to the investigator's judgment
- Ongoing behavioural treatment for tics
- History of schizophrenia, seizure, psychotic, severe personality, or pervasive developmental disorder
- Current clinical diagnosis of substance abuse or dependence
- History of cannabis dependence
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- Secondary and other chronic tic disorders or other significant neurological disorders
- Known severe cardiac diseases, known severe cardiovascular diseases, known positivity for human immunodeficiency virus (HIV), hepatitis C, hepatitis B, or other severe hepatic and renal disorders by history
- Concomitant medications have to be on stable dose since at least 6 weeks before entering the study and must be well tolerated at baseline without causing dizziness, confusion, sedation, or somnolence)
- Use of cannabis or cannabinoid-based medicine (CBM) in the 30-day period prior to study entry and/or positive delta-9-tetrahydrocannabinol (THC) urine test at baseline
- Positive urine ß-HCG pregnancy test
- Pregnant or breast-feeding women
- Subjects who received any investigational medication or used any investigational device within 30 days prior to the first dose of study medication or is actively participating in any investigational drug or device study, or is scheduled to receive an investigational drug or to use an investigational device during the course of the study
- Subjects with a known allergy, hypersensitivity, or intolerance to the active substances and ingredients of study medication (e.g., cannabis, cannabinoids, or sesame oil)
- Any condition, which in the opinion of the investigator, would interfere with the evaluation of the study product or poses a health risk to the subject
- Subjects who are employees of the sponsor or employees or close relatives of the investigator
- Subjects with active suicidal ideation and behaviour (SI/B) according to the Columbia-Suicide Severity Rating Scale (C-SSRS) and/or subjects that have attempted suicide in the past.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site
Yale Child Study Center - NIHB 205
New Haven, Connecticut, 06519
Michael Bloch, MD, MS, 203-745-9921, michael.bloch@yale.edu
Angeli Landeros-Weisenberger, MD, 203-745-9921, angeli.landeros@yale.edu
Germany1 site
Medizinische Hochschule Hannover
Hanover, 30625
Kirsten R Müller-Vahl, PhD. MD, +49 511 532 3551, mueller-vahl.kirsten@mh-hannover.de
Israel1 site
Neurological Institute, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Tanya Gurevich, PhD. MD, 972 3 6974912, tanyag@tlvmc.gov.il
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Evaluate the Efficacy, Safety and Tolerability of Daily Oral SCI-110 in Treating Adults With Tourette Syndrome.
To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.
Read the detailed description
It is believed that SCI-110 will be a valuable treatment option, especially for t those subjects with TS, who do not benefit from or do not tolerate first-line treatment with antipsychotics. Since there is evidence that currently available CBM improves not only tics, but also psychiatric comorbidities, SCI-110 might be even more beneficial to improve a broader spectrum of symptoms resulting in both improved quality of life and decreased disease related costs. Moreover, PEA was shown to minimize AEs associated with cannabinoids use and to reduce their required effective dose (data not published). Hence, the use of SCI-110 is expected to show a therapeutic effect superior to currently available CBMs.
It can be assumed that AEs in TS subjects do not differ from AEs described in other groups of subjects treated with medicinal cannabis and/or cannabinoids. In general, cannabinoids are considered as well tolerated.
- Conditions
- Tourette Syndrome
- Being tested
- SCI-110, Placebo
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCI-110Drug
SCI-110 - a softgel capsule containing Dronabinol and Palmitoylethanolamide (PEA) in the following doses: 2.5mg Dronabinol+400mg PEA, 5mg Dronabinol+400mg PEA and 10mg Dronabinol+400mg. Maximum dose 20mg Dronabinol and 800mg PEA a day.
PlaceboOther
Pill that matches in taste, odour and appearance to SCI-110 active pills
| Study group | Role | What they receive |
|---|---|---|
| SCI-110 | Experimental | Cannabinoid-based medication consisting of Dronabinol and PEA Receives: Drug: SCI-110 |
| Dronabinol | Placebo comparator | Placebo matched in taste, odour and appearance to SCI-110 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in revised version of Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS)
Absolute change from baseline in revised version of YGTSS-R-TTS as a continuous endpoint at week 12 of the respective treatment period.
The Global Severity Score has a range of 0- 100. A higher score on the scale suggests a more severe Tic, or a greater impact the Tic has on the person's life.
Measured: At baseline and 12 weeks after start of treatment in both arms.
Secondary outcomes (29)
Percent reduction in Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) of at least 20%
Response to treatment according to YGTSS-R-TTS of at least 20% reduction (compared to baseline)
The responder criterion defined as a more severe Tic, or a greater impact the Tic has on the person's life The Global Severity Score has a range of 0- 100. A higher score the scale suggests a more severe Tic, or a greater impact the Tic has on the person's life.
Measured: At baseline and 12 weeks after start of treatment in both arms.
Percent reduction in Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) of at least 30%, 35% and 50%
Response to treatment according to YGTSS-R-TTS responder criterion, defined as a percent reduction in YGTSS-R-TTS of at least 30%, 35% and 50% (compared to baseline) The Global Severity Score has a range of 0- 100. A higher score on the scale suggests a more severe Tic, or a greater impact the Tic has on the person's life.
Measured: Week 12 of each treatment period (visit 8 and 15).
Absolute change from baseline of YGTSS-R Total Score
Absolute change from baseline of YGTSS-R Total Score, the corresponding subdomain motor and phonic total tic scores, the YGTSS-R Impairment Score, as well as of the combination of the total tic score and the impairment score (YGTSS-R-GS (= YGTSS-R-TTS + YGTSS-R-impairment score).
Measured: At baseline and 12 weeks after start of treatment in both arms.
Percent change from baseline of YGTSS-R Total Score
Percent change from baseline of YGTSS-R Total Score, the corresponding subdomain motor and phonic total tic scores, the YGTSS-R Impairment Score, as well as of the combination of the total tic score and the impairment score (YGTSS-R-GS (= YGTSS-R-TTS + YGTSS-R-impairment score).
Measured: At baseline and 12 weeks after start of treatment in both arms.
Clinical Global Impression-Improvement Score (CGI-I)
Absolute values of the Clinical Global Impression-Improvement Score (CGI-I). CGI is a 7 point scale that ranges from 1 Very much improved to 7 Very much worse
Measured: 24 weeks
Clinical Global Impression-Severity Score (CGI-S) Absolute result
Absolute change from baseline of Clinical Global Impression-Severity Score (CGI-S).
CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
The range is from 1 Normal, not at all ill to 7 Among the most extremely ill patients
Measured: 24 weeks
Clinical Global Impression-Severity Score (CGI-S) Percent result
Percent change from baseline of Clinical Global Impression-Severity Score (CGI-S).
CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
The range is from 1 Normal, not at all ill to 7 Among the most extremely ill patients
Measured: 24 weeks
Total Pre-monitory Urge for Tics Scale (PUTS) Absolute Score
Absolute change from baseline of the total Pre-monitory Urge for Tics Scale (PUTS) Score.
The range of the test is between 9 - 36. A higher score on the scale indicates an extremely high intensity with probable severe impairment.
Measured: 24 weeks
Total Pre-monitory Urge for Tics Scale (PUTS) Percent Score
Percent change from baseline of the total Pre-monitory Urge for Tics Scale (PUTS) Score.
The range of the test is between 9 - 36. A higher score on the scale indicates an extremely high intensity with probable severe impairment.
Measured: 24 weeks
Adult Tic Questionnaire (ATQ) Percent Score
Percent change from baseline of the total Adult Tic Questionnaire (ATQ) Score. The Adult Tic Questionnaire (ATQ) Score has a range of 0- 50. A higher score on all scales suggests a more severe Tic, or a greater impact the Tic has on the person's life.
Measured: 24 weeks
Adult Tic Questionnaire (ATQ) Absolute Score
The absolute change from baseline of the total Adult Tic Questionnaire (ATQ) Score.
The Adult Tic Questionnaire (ATQ) Score has a range of 0- 50. A higher score on all scales suggests a more severe Tic, or a greater impact the Tic has on the person's life.
Measured: 24 weeks
Changes in Beck Depression Inventory (BDI-II) Percent score.
Percent change from baseline of the Beck Depression Inventory (BDI-II) total score The questionnaire contains about 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.
0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression
Measured: 24 weeks
Changes in Beck Depression Inventory (BDI-II) absolute score.
Absolute change from baseline of the Beck Depression Inventory (BDI-II) total score The questionnaire contains about 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.
0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression
Measured: 24 weeks
Changes in Yale-Brown Obsessive Compulsive Scale (Y BOCS) absolute score
Absolute change from baseline of the Yale-Brown Obsessive Compulsive Scale (Y BOCS) Total scores on the measure range from 0 to 40, with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms.
Measured: 24 weeks
Changes in Yale-Brown Obsessive Compulsive Scale (Y BOCS) Percent score
Percent change from baseline of the Yale-Brown Obsessive Compulsive Scale (Y BOCS) score.
Total scores on the measure range from 0 to 40, with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms.
Measured: 24 weeks
Changes in Obsessive-compulsive disorder (OCD) severity Absolute score
Absolute change from baseline of the total Obsessive-compulsive disorder (OCD) severity score.
The range of the test is between 8-15 = Mild OCD; 16-23 = Moderate OCD; 24-31= Severe OCD; 32-40 = Extreme OCD
Measured: 24 weeks
Changes in Obsessive-compulsive disorder (OCD) severity Percent score
Percent change from baseline of the total Obsessive-compulsive disorder (OCD) severity score.
The range of the test is between 8-15 = Mild OCD; 16-23 = Moderate OCD; 24-31= Severe OCD; 32-40 = Extreme OCD
Measured: 24 weeks
Changes in Conners' Adult ADHD Rating Scale (CAARS) Absolute score.
Absolute change from baseline of the Conners' Adult ADHD Rating Scale (CAARS) score.
When total score is less than 60 there is no indication of ADHD. A score higher than 60 may indicate ADHD. And a total score higher than 70 means ADHD with more serious symptoms.
Measured: 24 weeks
Changes in Conners' Adult ADHD Rating Scale (CAARS) Percent score
Percent change from baseline of the Conners' Adult ADHD Rating Scale (CAARS) score When total score is less than 60 there is no indication of ADHD. A score higher than 60 may indicate ADHD. And a total score higher than 70 means ADHD with more serious symptoms.
Measured: 24 weeks
Changes in Beck Anxiety Inventory (BAI) Absolute scores
Absolute and percent change from baseline of the Beck Anxiety Inventory (BAI) The BAI assessments contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are: 0-7: Minimal, 8-15: Mild, 16-25: Moderate and 26-63: Severe
Measured: 24 weeks
Changes in Beck Anxiety Inventory (BAI) percent scores
Percent change from baseline of the Beck Anxiety Inventory (BAI) score. The BAI assessments contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are: 0-7: Minimal, 8-15: Mild, 16-25: Moderate and 26-63: Severe
Measured: 24 weeks
Changes in Beck Depression Inventory (BDI) Absolute score
Absolute change from baseline of the total BDI score. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows: 0-9: indicates minimal depression, 10-18: indicates mild depression, 19-29: indicates moderate depression, 30-63: indicates severe depression. Higher total scores indicate more severe depression
Measured: 24 weeks
Changes in Beck Depression Inventory (BDI) percent score
Percent change from baseline of the total BDI score. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows: 0-9: indicates minimal depression, 10-18: indicates mild depression, 19-29: indicates moderate depression, 30-63: indicates severe depression. Higher total scores indicate more severe depression
Measured: 24 weeks
Changes in Rage Attacks Questionnaire (RAQ-R) Absolute scores
Absolute change from baseline of the Rage Attacks Questionnaire (RAQ-R) score. The RAQ-R assessments contains 22 questions, each answer being scored on a scale value of 0 (not at all) to 4 (Very powerful, very common). Higher total scores indicate more severe Rage Attacks.
Measured: 24 weeks
Changes in Rage Attacks Questionnaire (RAQ-R) percent scores
Percent change from baseline of the Rage Attacks Questionnaire (RAQ-R) score. The RAQ-R assessments contains 22 questions, each answer being scored on a scale value of 0 (not at all) to 4 (Very powerful, very common). Higher total scores indicate more severe Rage Attacks.
Measured: 24 weeks
Changes in Pittsburgh Sleep Quality Index (PSQI) Absolute scores
Absolute change from baseline of the Pittsburgh Sleep Quality Index (PSQI) global score.
PSQI Consisting of 19 items, Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 24 weeks
Changes in Pittsburgh Sleep Quality Index (PSQI) Percent scores
Percent change from baseline of the Pittsburgh Sleep Quality Index (PSQI) global score.
PSQI Consisting of 19 items, Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 24 weeks
Changes to the Tourette Syndrome-Quality of Life Scale (GTS-QoL) score
Changes from baseline of Tourette Syndrome-Quality of Life Scale (GTS-QoL). GTS-QoL is a 27-item, self-report questionnaire that assesses HR-QoL in young patients with tic disorders, encompassing 4 areas of HR-QoL: psychological, physical/activities of daily living, obsessive-compulsive, and cognitive domains. Each item is rated on a 5-point Likert-type scale and higher scores indicate worse HR-QoL. The instrument includes a Visual Analogue Scale used to express the extent of self-satisfaction about life (higher scores indicate higher satisfaction)
Measured: 24 weeks
Changes to the 12-item short-form Health Survey (SF-12) score
Changes from baseline of 12-item short-form Health Survey (SF-12). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study startJun 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurothera Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsten R Müller-Vahl, PhD. MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126888
- Sponsor's protocol ID
- SCI-021-001
- Status last verified
- May 2025
- First submitted
- 25 Oct 2021
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Evaluate the Efficacy, Safety and Tolerability of Daily Oral SCI-110 in Treating Adults With Tourette Syndrome.
- ClinicalTrials.gov ID
- NCT05126888
- Acronym / sponsor ID
- SCI-021-001
- Conditions
- Tourette Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Neurothera Labs Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.
Detailed description
It is believed that SCI-110 will be a valuable treatment option, especially for t those subjects with TS, who do not benefit from or do not tolerate first-line treatment with antipsychotics. Since there is evidence that currently available CBM improves not only tics, but also psychiatric comorbidities, SCI-110 might be even more beneficial to improve a broader spectrum of symptoms resulting in both improved quality of life and decreased disease related costs. Moreover, PEA was shown to minimize AEs associated with cannabinoids use and to reduce their required effective dose (data not published). Hence, the use of SCI-110 is expected to show a therapeutic effect superior to currently available CBMs.
It can be assumed that AEs in TS subjects do not differ from AEs described in other groups of subjects treated with medicinal cannabis and/or cannabinoids. In general, cannabinoids are considered as well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCI-110 | Experimental | Drug: SCI-110Cannabinoid-based medication consisting of Dronabinol and PEA |
| Dronabinol | Placebo comparator | Other: PlaceboPlacebo matched in taste, odour and appearance to SCI-110 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Tourette syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
- Male and female subjects with an age between ≥18 and ≤65 years
- Total tic score (TTS) of the revised Yale Global Tic Severity Scale (YGTSS-R) \>14
- Clinical Global Impression-Severity Score (CGI-S) ≥4
- Medication (and stimulation parameters for deep brain stimulation) for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study and subject must consent to maintain the stable dose during the study
Key exclusion criteria (17 listed)
- Comorbid obsessive-compulsive disorder (OCD), attention deficit/hyperactivity disorder (ADHD), depression, and anxiety disorder when unstable or in need of an initial adjustment for a therapy-according to the investigator's judgment
- Presence of severe psychiatric conditions such as developmental disability, psychotic illness and bipolar disorder- according to the investigator's judgment
- Ongoing behavioural treatment for tics
- History of schizophrenia, seizure, psychotic, severe personality, or pervasive developmental disorder
- Current clinical diagnosis of substance abuse or dependence
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 |
|---|---|---|
| SCI-110SCI-110 - a softgel capsule containing Dronabinol and Palmitoylethanolamide (PEA) in the following doses: 2.5mg Dronabinol+400mg PEA, 5mg Dronabinol+400mg PEA and 10mg Dronabinol+400mg. Maximum dose 20mg Dronabinol and 800mg PEA a day. | Drug | SCI-110 |
| PlaceboPill that matches in taste, odour and appearance to SCI-110 active pills | Other | Dronabinol |
Primary outcome
Absolute change from baseline in revised version of Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS)
Time frame: At baseline and 12 weeks after start of treatment in both arms.
Absolute change from baseline in revised version of YGTSS-R-TTS as a continuous endpoint at week 12 of the respective treatment period. The Global Severity Score has a range of 0- 100. A higher score on the scale suggests a more severe Tic, or a greater impact the Tic has on the person's life.
29 secondary outcomes
Percent reduction in Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) of at least 20%
Time frame: At baseline and 12 weeks after start of treatment in both arms.
Percent reduction in Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) of at least 30%, 35% and 50%
Time frame: Week 12 of each treatment period (visit 8 and 15).
Absolute change from baseline of YGTSS-R Total Score
Time frame: At baseline and 12 weeks after start of treatment in both arms.
Percent change from baseline of YGTSS-R Total Score
Time frame: At baseline and 12 weeks after start of treatment in both arms.
Clinical Global Impression-Improvement Score (CGI-I)
Time frame: 24 weeks
Clinical Global Impression-Severity Score (CGI-S) Absolute result
Time frame: 24 weeks
Clinical Global Impression-Severity Score (CGI-S) Percent result
Time frame: 24 weeks
Total Pre-monitory Urge for Tics Scale (PUTS) Absolute Score
Time frame: 24 weeks
Total Pre-monitory Urge for Tics Scale (PUTS) Percent Score
Time frame: 24 weeks
Adult Tic Questionnaire (ATQ) Percent Score
Time frame: 24 weeks
Adult Tic Questionnaire (ATQ) Absolute Score
Time frame: 24 weeks
Changes in Beck Depression Inventory (BDI-II) Percent score.
Time frame: 24 weeks
Changes in Beck Depression Inventory (BDI-II) absolute score.
Time frame: 24 weeks
Changes in Yale-Brown Obsessive Compulsive Scale (Y BOCS) absolute score
Time frame: 24 weeks
Changes in Yale-Brown Obsessive Compulsive Scale (Y BOCS) Percent score
Time frame: 24 weeks
Changes in Obsessive-compulsive disorder (OCD) severity Absolute score
Time frame: 24 weeks
Changes in Obsessive-compulsive disorder (OCD) severity Percent score
Time frame: 24 weeks
Changes in Conners' Adult ADHD Rating Scale (CAARS) Absolute score.
Time frame: 24 weeks
Changes in Conners' Adult ADHD Rating Scale (CAARS) Percent score
Time frame: 24 weeks
Changes in Beck Anxiety Inventory (BAI) Absolute scores
Time frame: 24 weeks
Changes in Beck Anxiety Inventory (BAI) percent scores
Time frame: 24 weeks
Changes in Beck Depression Inventory (BDI) Absolute score
Time frame: 24 weeks
Changes in Beck Depression Inventory (BDI) percent score
Time frame: 24 weeks
Changes in Rage Attacks Questionnaire (RAQ-R) Absolute scores
Time frame: 24 weeks
Changes in Rage Attacks Questionnaire (RAQ-R) percent scores
Time frame: 24 weeks
Changes in Pittsburgh Sleep Quality Index (PSQI) Absolute scores
Time frame: 24 weeks
Changes in Pittsburgh Sleep Quality Index (PSQI) Percent scores
Time frame: 24 weeks
Changes to the Tourette Syndrome-Quality of Life Scale (GTS-QoL) score
Time frame: 24 weeks
Changes to the 12-item short-form Health Survey (SF-12) score
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- 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.
Kirsten R Müller-Vahl, PhD. MD principal investigator
Hannover Medical School
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCI-110 in people with Tourette Syndrome, run by Neurothera Labs Inc. at 3 sites in 3 countries.
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 13 inclusion and 17 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: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany, Israel. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adi Zuloff-Shani, PhD (972-3-7175777, adi@scisparc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline in revised version of Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) (time frame: At baseline and 12 weeks after start of treatment in both arms.). 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 21 Apr 2026.