SCI-110 in the Treatment of Tourette Syndrome

NCT05126888 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SCI-021-001
• Study Type: interventional
• Target: 164
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  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%

  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%

  Week 12 of each treatment period (visit 8 and 15).

• Absolute change from baseline of YGTSS-R Total Score

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

• Percent change from baseline of YGTSS-R Total Score

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

• Clinical Global Impression-Improvement Score (CGI-I)

  24 weeks

Other Outcomes (4)

• Number and rate of patients affected by AEs, SAEs, SUSARs/ADRs, AESIs and AEs

  24 weeks

• Absolute values of vital sign blood pressure at each visit and change from baseline.

  24 weeks

• Absolute values of vital sign heart rate at each visit and change from baseline.

  24 weeks

Study Arms (2)

SCI-110

EXPERIMENTAL

Cannabinoid-based medication consisting of Dronabinol and PEA

Drug: SCI-110

Dronabinol

PLACEBO COMPARATOR

Placebo matched in taste, odour and appearance to SCI-110

Other: Placebo

Interventions

SCI-110 DRUG

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.

SCI-110

Placebo OTHER

Pill that matches in taste, odour and appearance to SCI-110 active pills

Dronabinol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Neurothera Labs Inc.: lead

Study Sites (3)

Yale Child Study Center - NIHB 205

New Haven, Connecticut, 06519, United States

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Neurological Institute, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kirsten R Müller-Vahl, PhD. MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adi Zuloff-Shani, PhD

CONTACT

972-3-7175777; adi@scisparc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 19, 2021
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IL (1); DE (1)