Chronic tic disorders and Tourette syndrome MedDRA version: 20.0 Level: HLT Classification code 10043835 Term: Tic disorders System Organ Class: 100000004873 MedDRA version: 20.0 Level: LLT Classification code 10018269 Term: Gilles de la Tourette syndrome System Organ Class: 100000004850
Conditions
Interventions
Trade Name: Sativex
Pharmaceutical Form: Oromucosal spray, solution
INN or Proposed INN: dronabinol
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic tic disorder or Tourette syndrome according to DSM-5 2. Age =18 years 3. YGTSS-TTS > 14 for patients with Tourette syndrome or YGTSS-TTS > 10 for patients with chronic motor or vocal tics only (= CTD) 4. 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 30 days before entering the study and patient 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. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial 8. Prevention of pregnancy: 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 • 40 IU/l and urine oestrogen =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. One of the following conditions when unstable or in need of an initial adjustment for a therapy: Comorbid OCD, ADHD, depression, and anxiety disorder 2. Ongoing behavioural treatment for tics 3. History of schizophrenia, psychotic, severe personality, or pervasive developmental disorder 4. Patient has a history of suicidal ideation with intent to act or a plan to act in the 12 months preceding the Screening Visit 5. Current clinical diagnosis of substance abuse or dependence and compulsive disorder 6. Secondary tic disorders and other significant neurological disorders that, in the opinion of the investigator, might interfere with the patient’s participation in the study, poses added risk for the patient, or confounds the assessment of patient safety 7. Severe cardiovascular diseases, hepatitis C, or other severe hepatic and renal disorders by history that, in the opinion of the investigator, might interfere with the patient’s participation in the study, poses added risk for the patient, or confounds the assessment of patient safety 8. Any medical condition based on medical history, physical examination, and vital sign measurements that, in the opinion of the Investigator, might interfere with the patient’s participation in the study, poses added risk for the patient, or confounds the assessment of patient safety 9. Use of cannabis or CBM in the 30-day period prior to study entry and/or positive THC urine test 10. Positive urine pregnancy test 11. Pregnancy or lactation period 12. The subject has 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 13. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that treatment with the cannabis extract nabiximols is superior to placebo in reducing tics and comorbidities in patients with Tourette syndrome and chronic tic disorders;Secondary Objective: Not applicable; Primary end point(s): Primary efficacy endpoint: Response to treatment according to YGTSS-TTS, defined as a reduction in YGTSS-TTS of at least 30% (compared to baseline) after 9 weeks of stable treatment ;Timepoint(s) of evaluation of this end point: After 9 weeks of stable treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoint: fitness to drive after 9 weeks of stable treatment as a binary criterion according to the Vienna Test System (a patient is fit to drive if none of the following tests has a percent rank below 16: Reaction time and choice reaction (RT), Stress Behavior capacity (DT-Auslastung), Stress Behavious performance quantity (DT_Mengenleistung), Concentration (COG), and Perceptual speed (ATAVT)). Further secondary endpoints: individual fitness to drive scores (RT, DT-Auslastung, DT-Mengenleistung, COG, ATAVT) after 9 weeks of stable treatment, YGTSS-TTS as a continuous endpoint (change from baseline) after 9 weeks of stable treatment. YGTSS-TTS as a binary responder criterion as well as a continuous endpoint after 4 weeks stable treatment and 1 month after end of treatment. The following efficacy endpoints will be assessed after 4 and 9 weeks stable treatment and 1 month after end of treatment: Yale Global Tic Severity Scale-Global Score (YGTSS-GS), modified Rush Video-Based Tic Rating Scale (MRVS), Clinical Global Impression–Improvement Score (CGI-I), Clinical Global Impression–Severity Score (CGI-S), Adult Tic Questionnaire (ATQ), Tourette syndrome-quality of life scale (GTS-QoL), Pre-monitory Urge for Tics Scale (PUTS), Beck Depression Inventory-II (BDI-II), Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Conners' Adult ADHD Rating Scale (CAARS), Beck Anxiety Inventory (BAI), Pittsburgh Sleep Quality Index (PSQI), Skala Impulsives-Verhalten-8 (I-8), 12-item short-form Health Survey (SF-12), and Rage attacks questionnaire for adults (RAQ). Assessment of safety: (Serious) adverse events (AEs/SAEs), blood pressure, and pulse at each visit. An independent Data Monitoring Committee (DMC) will be established. ; Timepoint(s) of evaluation of this end point: Key secondary endpoints: after 9 weeks of stable treatment | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Kirsten R. Müller-Vahl
Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy
Outcome results
None listed