SCI-110 in the Treatment of Tourette Syndrome

NCT ID: NCT05126888

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-02-28

Brief Summary

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

Detailed Description

It is believed that SCI-110 will be a valuable treatment option, especially for t those subjects with TS, who do not benefit from or do not tolerate first-line treatment with antipsychotics. Since there is evidence that currently available CBM improves not only tics, but also psychiatric comorbidities, SCI-110 might be even more beneficial to improve a broader spectrum of symptoms resulting in both improved quality of life and decreased disease related costs. Moreover, PEA was shown to minimize AEs associated with cannabinoids use and to reduce their required effective dose (data not published). Hence, the use of SCI-110 is expected to show a therapeutic effect superior to currently available CBMs.

It can be assumed that AEs in TS subjects do not differ from AEs described in other groups of subjects treated with medicinal cannabis and/or cannabinoids. In general, cannabinoids are considered as well tolerated.

Conditions

Tourette Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SCI-110

Cannabinoid-based medication consisting of Dronabinol and PEA

Group Type: EXPERIMENTAL

SCI-110

Intervention Type: 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.

Dronabinol

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

SCI-110

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SciSparc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsten R Müller-Vahl, PhD. MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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

Countries

United States; Germany; Israel

Central Contacts

Adi Zuloff-Shani, PhD

Role: CONTACT

adi@scisparc.com

972-3-7175777

Facility Contacts

Michael Bloch, MD, MS

Role: primary

michael.bloch@yale.edu

203-745-9921

Angeli Landeros-Weisenberger, MD

Role: backup

angeli.landeros@yale.edu

203-745-9921

Kirsten R Müller-Vahl, PhD. MD

Role: primary

mueller-vahl.kirsten@mh-hannover.de

+49 511 532 3551

Tanya Gurevich, PhD. MD

Role: primary

tanyag@tlvmc.gov.il

972 3 6974912

Other Identifiers

SCI-021-001

Identifier Type: -

Identifier Source: org_study_id