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A Phase IIb Study to Determine the Safety, Tolerability and Efficacy of a Daily Oral Dose of SCI-110 in Adult Patients with Tourette's Syndrome (TS)
EU CTIS ID: 2024-512949-17-00
What this study is testing
Primary efficacy objective: [CCI]
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- TS according to DSM-5
- Male and female subjects with an age between ≥18 and ≤65 years
- Total tic score (TTS) of the YGTSS-R >14
- 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
You likely can't join if
- Comorbid OCD, ADHD, depression, and anxiety disorder when unstable and/or in need of an initial adjustment for a therapy
- Use of cannabis or CBM in the 30-day period prior to study entry and/or positive delta-9-THC urine test at baseline
- Positive urine beta-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 excipients of study medication (e.g., cannabis, cannabinoids, etc.)
See the full eligibility criteria
Who can join
- TS according to DSM-5
- Male and female subjects with an age between ≥18 and ≤65 years
- Total tic score (TTS) of the YGTSS-R >14
- 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 a 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.
- 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.
What rules you out
- Comorbid OCD, ADHD, depression, and anxiety disorder when unstable and/or in need of an initial adjustment for a therapy
- Use of cannabis or CBM in the 30-day period prior to study entry and/or positive delta-9-THC urine test at baseline
- Positive urine beta-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 excipients of study medication (e.g., cannabis, cannabinoids, etc.)
- 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
- Presence of comorbid psychiatric conditions: developmental disability, psychotic illness and bipolar disorder
- Subjects who suffer from Cirrhosis of the Liver based on the Child-Pugh Scoring System (Child A to C)
- 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 or current cannabis dependence
- Secondary and other chronic tic disorders or other significant neurological disorders
- Known severe cardiac diseases, known severe cardiovascular diseases, known positive for human immunodeficiency virus (HIV), known hepatitis C, known 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 such as central nervous system depressants (e.g., antipsychotics, barbiturates, benzodiazepines, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.