Clinical trial NCT05126888: SCI-110 in the Treatment of Tourette Syndrome
Official title: A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Evaluate the Efficacy, Safety and Tolerability of Daily Oral SCI-110 in Treating Adults With Tourette Syndrome.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Tourette Syndrome
Lead sponsor: SciSparc
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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) \&gt;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
   * \&lt; 50 years and in postmenopausal state ≥ 1 year with urine FSH \&gt; 40 IU/l and urine oestrogen \&lt; 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Percent reduction in Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) of at least 20%
timeFrame: At baseline and 12 weeks after start of treatment in both arms.
measure: Percent reduction in Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) of at least 30%, 35% and 50%
timeFrame: Week 12 of each treatment period (visit 8 and 15).
measure: Absolute change from baseline of YGTSS-R Total Score
timeFrame: At baseline and 12 weeks after start of treatment in both arms.
measure: Percent change from baseline of YGTSS-R Total Score
timeFrame: At baseline and 12 weeks after start of treatment in both arms.
measure: Clinical Global Impression-Improvement Score (CGI-I)
timeFrame: 24 weeks
measure: Clinical Global Impression-Severity Score (CGI-S) Absolute result
timeFrame: 24 weeks
measure: Clinical Global Impression-Severity Score (CGI-S) Percent result
timeFrame: 24 weeks
measure: Total Pre-monitory Urge for Tics Scale (PUTS) Absolute Score
timeFrame: 24 weeks
measure: Total Pre-monitory Urge for Tics Scale (PUTS) Percent Score
timeFrame: 24 weeks
measure: Adult Tic Questionnaire (ATQ) Percent Score
timeFrame: 24 weeks
measure: Adult Tic Questionnaire (ATQ) Absolute Score
timeFrame: 24 weeks
measure: Changes in Beck Depression Inventory (BDI-II) Percent score.
timeFrame: 24 weeks
measure: Changes in Beck Depression Inventory (BDI-II) absolute score.
timeFrame: 24 weeks
measure: Changes in Yale-Brown Obsessive Compulsive Scale (Y BOCS) absolute score
timeFrame: 24 weeks
measure: Changes in Yale-Brown Obsessive Compulsive Scale (Y BOCS) Percent score
timeFrame: 24 weeks
measure: Changes in Obsessive-compulsive disorder (OCD) severity Absolute score
timeFrame: 24 weeks
measure: Changes in Obsessive-compulsive disorder (OCD) severity Percent score
timeFrame: 24 weeks
measure: Changes in Conners' Adult ADHD Rating Scale (CAARS) Absolute score.
timeFrame: 24 weeks
measure: Changes in Conners' Adult ADHD Rating Scale (CAARS) Percent score
timeFrame: 24 weeks
measure: Changes in Beck Anxiety Inventory (BAI) Absolute scores
timeFrame: 24 weeks
measure: Changes in Beck Anxiety Inventory (BAI) percent scores
timeFrame: 24 weeks
measure: Changes in Beck Depression Inventory (BDI) Absolute score
timeFrame: 24 weeks
measure: Changes in Beck Depression Inventory (BDI) percent score
timeFrame: 24 weeks
measure: Changes in Rage Attacks Questionnaire (RAQ-R) Absolute scores
timeFrame: 24 weeks
measure: Changes in Rage Attacks Questionnaire (RAQ-R) percent scores
timeFrame: 24 weeks
measure: Changes in Pittsburgh Sleep Quality Index (PSQI) Absolute scores
timeFrame: 24 weeks
measure: Changes in Pittsburgh Sleep Quality Index (PSQI) Percent scores
timeFrame: 24 weeks
measure: Changes to the Tourette Syndrome-Quality of Life Scale (GTS-QoL) score
timeFrame: 24 weeks
measure: Changes to the 12-item short-form Health Survey (SF-12) score
timeFrame: 24 weeks
Other outcomes:
measure: Number and rate of patients affected by AEs, SAEs, SUSARs/ADRs, AESIs and AEs
timeFrame: 24 weeks
measure: Absolute values of vital sign blood pressure at each visit and change from baseline.
timeFrame: 24 weeks
measure: Absolute values of vital sign heart rate at each visit and change from baseline.
timeFrame: 24 weeks
measure: 2.3. Suicide risk assessment measured by the Columbia-Suicide Severity Rating Scale (CSSRS)
timeFrame: Through out the study
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center - NIHB 205
state: Connecticut
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Tel Aviv
country: Israel
facility: Neurological Institute, Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Hannover Medical School
name: Kirsten R Müller-Vahl, PhD. MD
role: PRINCIPAL_INVESTIGATOR
References: