Not Yet RecruitingPhase 2

SCI-110 in the Treatment of Tourette Syndrome

United States, Germany, Israel164 participantsStarted 2026-06

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:

✕. 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

Absolute change from baseline in revised version of Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS)

Timeframe: At baseline and 12 weeks after start of treatment in both arms.

NCT IDNCT05126888

SponsorNeurothera Labs Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10

Adi Zuloff-Shani, PhD

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:

✕. 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