SCI-110 in the Treatment of Tourette Syndrome

Официальное название

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.

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат 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.
• Другое Placebo
  Pill that matches in taste, odour and appearance to SCI-110 active pills

Первичные конечные точки

• Absolute change from baseline in revised version of Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) [Срок оценки: At baseline and 12 weeks after start of treatment in both arms.]

Вторичные конечные точки (12)

• Percent reduction in Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) of at least 20% [Срок оценки: 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% [Срок оценки: Week 12 of each treatment period (visit 8 and 15).]
• Absolute change from baseline of YGTSS-R Total Score [Срок оценки: At baseline and 12 weeks after start of treatment in both arms.]
• Percent change from baseline of YGTSS-R Total Score [Срок оценки: At baseline and 12 weeks after start of treatment in both arms.]
• Clinical Global Impression-Improvement Score (CGI-I) [Срок оценки: 24 weeks]
• Clinical Global Impression-Severity Score (CGI-S) Absolute result [Срок оценки: 24 weeks]
• Clinical Global Impression-Severity Score (CGI-S) Percent result [Срок оценки: 24 weeks]
• Total Pre-monitory Urge for Tics Scale (PUTS) Absolute Score [Срок оценки: 24 weeks]
• Total Pre-monitory Urge for Tics Scale (PUTS) Percent Score [Срок оценки: 24 weeks]
• Adult Tic Questionnaire (ATQ) Percent Score [Срок оценки: 24 weeks]
• Adult Tic Questionnaire (ATQ) Absolute Score [Срок оценки: 24 weeks]
• Changes in Beck Depression Inventory (BDI-II) Percent score. [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Subjects who are employees of the sponsor or employees or close relatives of the investigator
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Yale Child Study Center - NIHB 205 — New Haven

Германия · 1 центр

• Medizinische Hochschule Hannover — Hanover

Израиль · 1 центр

• Neurological Institute, Tel Aviv Sourasky Medical Center — Tel Aviv

Идентификаторы

NCT: NCT05126888 · SCI-021-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗