A Phase IIa Study to Determine the Safety, Tolerability and Efficacy of a daily oral dose of THX-110 in Adult Patients with Tourette Syndrome (TS)
- Conditions
- Tourette SyndromeMedDRA version: 20.0 Level: LLT Classification code 10044127 Term: Tourette's syndrome System Organ Class: 100000004850Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-000014-38-DE
- Lead Sponsor
- Therapix Biosciences Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
1.Tourette syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5. Edition (DSM-5)
2.Male and female subjects with an age between =18 and <65 years
3.Total tic score (TTS) of the Yale Global Tic Severity Scale (YGTSS) >18
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 (i.e., negative for 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. Post-menopausal women may enter this study. Post-menopausal women are defined as those without menses in the past 12 months without an alternative medical cause, and with a serum follicle stimulating hormone (FSH) in the post-menopausal range. Women who are surgically sterile may enter this study with historical documentation of surgical procedure (bilateral tubal ligation or bilateral oophorectomy at least 6 weeks prior screening or hysterectomy or uterine agenesis) and a negative pregnancy 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Comorbid obsessive-compulsive disorder (OCD), attention deficit/hyperactivity disorder (ADHD), depression, or anxiety disorder when unstable and/or in need of an initial adjustment for a therapy
2.Presence of a comorbid psychiatric condition as developmental disability, psychotic illness or bipolar disorder
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.History of severe cardiac diseases, severe cardiovascular diseases, severe renal disorders, or severe hepatic disorders and/or positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
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 such as central nervous system depressants (e.g., barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants)
10.Use of cannabis or cannabis-based medicine (CBM) in the 30-day period prior to study entry and/or positive delta-9-tetrahydrocannabinol urine test at baseline
11.Positive pregnancy test, i.e., positive for urine beta-hCG
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To evaluate the efficacy of the cannabinoids-based medication THX 110 compared to placebo in subjects with Tourette syndrome and to generate data for estimation of sample size and dose range for a larger RCT assessing efficacy of THX-110.<br> ;Secondary Objective: Not applicable;Primary end point(s): Primary efficacy endpoint: Absolute change in YGTSS-TTS as a continuous endpoint at week 12 of the double-blind phase (visit 9) compared to baseline. ;Timepoint(s) of evaluation of this end point: The primary analysis will use continuous change in YGTSS-TTS at week 12 of the double-blind phase (visit 9) compared to baseline.
- Secondary Outcome Measures
Name Time Method