SCI-110 in the Treatment of Tourette Syndrome

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Tourette Syndrome

In brief

To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.

Key facts

Study ID: NCT05126888
Run by: Neurothera Labs Inc.
People needed: 164
Starts: 2026-06-01
Expected to finish: 2028-02-01
Last updated by the study team: 2026-04-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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

You may not qualify if…

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
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.

Where it is running

Yale Child Study Center - NIHB 205 — New Haven, Connecticut, United States
Medizinische Hochschule Hannover — Hanover, Germany
Neurological Institute, Tel Aviv Sourasky Medical Center — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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