Could a daily cannabinoid pill tame tourette tics?
NCT ID NCT05126888
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a daily oral medication called SCI-110, made from cannabinoids, to see if it can safely reduce tics in adults with Tourette syndrome. About 164 adults aged 18 to 65 with moderate to severe tics will receive either the drug or a placebo, then switch after 12 weeks. The main goal is to measure changes in tic severity using a standard rating scale.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Tourette syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) 2. Male and female subjects with an age between ≥18 and ≤65 years 3. Total tic score (TTS) of the revised Yale Global Tic Severity Scale (YGTSS-R) \>14 4. Clinical Global Impression-Severity Score (CGI-S) ≥4 5. 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 6. Signed written informed consent and willingness to comply with treatment and follow-up procedures 7. Subjects capable of understanding the investigational nature, potential risks and benefits of the clinical study 8. 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. 9. 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 Exclusion Criteria: 1. 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 2. Presence of severe psychiatric conditions such as developmental disability, psychotic illness and bipolar disorder- according to the investigator's judgment 3. Ongoing behavioural treatment for tics 4. History of schizophrenia, seizure, psychotic, severe personality, or pervasive developmental disorder 5. Current clinical diagnosis of substance abuse or dependence 6. History of cannabis dependence 7. Secondary and other chronic tic disorders or other significant neurological disorders 8. 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 9. 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) 10. 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 11. Positive urine ß-HCG pregnancy test 12. Pregnant or breast-feeding women 13. 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 14. Subjects with a known allergy, hypersensitivity, or intolerance to the active substances and ingredients of study medication (e.g., cannabis, cannabinoids, or sesame oil) 15. 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 16. Subjects who are employees of the sponsor or employees or close relatives of the investigator 17. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medizinische Hochschule Hannover
Hanover, 30625, Germany
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Neurological Institute, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
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Yale Child Study Center - NIHB 205
New Haven, Connecticut, 06519, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A common antidepressant may tame anxiety in kids with autism and ADHD — a trial puts it to the test
- Brain scans may reveal why behavioral therapy helps some teens with tics
- Can a dopamine-blocking drug safely control tourette syndrome over years?
- Mapping tic patterns could lead to personalized therapy for tourette syndrome
- Sound waves aimed at the brain could quiet tics without surgery
- Wrist zap may tame tics: electrical pulses tested as Drug-Free option