Tourette Syndrome MedDRA version: 20.0 Level: LLT Classification code 10044127 Term: Tourette's syndrome System Organ Class: 100000004850
Conditions
Interventions
Trade Name: Dronabinol Capsules, USP
Product Name: THX-110 [Dronabinol]
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: DRONABINOL
Sponsors
Therapix Biosciences Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary efficacy endpoints: Response to treatment according to YGTSS-TTS responder criterion, defined as a reduction in YGTSS-TTS of at least 20% (compared to baseline) at week 12 of the double-blind phase (visit 9). Secondary endpoints: YGTSS-TTS as a binary responder criterion as well as a continuous endpoint at week 7 of the double-blind phase (visit 7). The following efficacy endpoints will be assessed at weeks 7 and 12 of the double-blind phase (visits 7 and 9): YGTSS-GS (= YGTSS-TTS + YGTSS-impairment score), modified Rush Video-Based Tic Rating Scale (MRVS), Clinical Global Impression-Improvement Score (CGI-I), CGI-S, Adult Tic Questionnaire (ATQ), Tourette Syndrome-Quality of Life Scale (GTS-QoL), Pre-monitory Urge for Tics Scale (PUTS), Beck Depression Inventory (BDI), Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Conners’ Adult ADHD Rating Scale (CAARS), Beck Anxiety Inventory (BAI), Pittsburgh Sleep Quality Index (PSQI), 12-item short-form (SF-12) Health Survey, Rage Attacks Questionnaire (RAQ). For the two visits in the maintenance phase of the extension open label phase (visits 12 and 13), the same endpoints will be evaluated as for the double-blind phase. ; Timepoint(s) of evaluation of this end point: Key secondary endpoint is the response to treatment according to YGTSS-TTS, defined as a reduction in YGTSS-TTS of at least 20% (compared to baseline) at week 12 of the double-blind phase (visit 9). Further secondary endpoints (YGTSS-TTS at week 7 of the double-blind phase; YGTSS-GS [= YGTSS-TTS + YGTSS-impairment score], MRVS, CGI-I, CGI-S, ATQ, GTS-QoL, PUTS, BDI, Y BOCS, CAARS, BAI, PSQI, SF-12, and RAQ at weeks 7 and 12 of the double-blind phase [visits 7 and 9]) will be analyzed in line with the primary and key secondary analysis. | — |
Countries
Germany
Contacts
Public ContactDr. Adi Zuloff-Shani, PhD, CTO
Therapix Biosciences Ltd.
Outcome results
None listed