CANNA-TICS

Overview
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A randomized multi-centre double-blind placebo controlled trial to demonstrate theefficacy and safety of nabiximols in the treatment of adults with chronic tic disorders

SEEK ID: https://ldh.zks-mhh.imise.uni-leipzig.de/projects/4

Public web page: Not specified

NFDI4Health PALs: No PALs for this Project

Project start date: 6th Jun 2025

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : A randomized multi-centre double-blind placebo controlled trial to demonstrate the efficacy and safety of nabiximols in the treatment of adults with chronic tic disorders
Language of the title/name : English

Acronym(s) of the Project

Acronym : CANNAbinoids in the treatment of TICS (CANNA-TICS)
Language of the acronym : English

Description(s) of the Project

Description : This is a multicentre, randomized, double-blind, placebo controlled, parallel-group, phase IIIb trial. Patients (≥18 years) with chronic tic disorders and Tourette syndrome will be recruited. The objective of the trial is 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.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Cannabinoid

Keyword(*) : TIC

Keyword(*) : Tourette syndrome

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Kirsten R.
Family name(s)(*) : Müller-Vahl
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Mueller-Vahl.Kirsten@mh-hannover.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Hannover Medical School
Address : Carl-Neuberg-Straße 1, 30625 Hannover
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : EudraCT
Identifier(*) : 2016-000564-42

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Gilles de la Tourette syndrome
Terminology/classification(*) : MedDRA
Code of the health condition or disease : 10018269
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Mental and behavioural disorders (V)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Not specified
Start date : 5 April 2018
End date : 20 November 2020
Mono- or multicentric? : Multicentric
Number of centers : 6
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
Inclusion criteria : Chronic tic disorder or Tourette syndrome according to DSM-5 Age ≥18 years Total tic score of the Yale Global Tic Severity Scale (YGTSS-TTS) > 14 for patients with Tourette syndrome or YGTSS-TTS > 10 for patients with chronic motor or vocal tics only (= CTD) 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 30 days before entering the study and patient must consent to maintain the stable dose during the study Signed written informed consent and willingness to comply with treatment and follow-up procedures Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial 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 < 50 years and in postmenopausal state ≥ 1 year with urine FSH > 40 IU/l and urine oestrogen < 30 ng/l or a negative oestrogen test or Women of childbearing potential with a negative urine ß-HCG pregnancy test at screening who agree to meet one of the following criteria from the time of screening, during the study and for a period of three months following the last administration of study medication: correct use of contraception methods. The following are acceptable: hormonal contraceptives (combined oral contraceptives, oestrogen-free pills with desogestrel, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUS) true abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception) sexual relationship only with female partners and/or sterile male partners or Males who are not surgically sterile and who are sexually active with female partner(s) of childbearing potential must agree to correct use of one of the following contraception methods from the time of screening, during the study and for a period of three months following the last administration of study medication: hormonal contraceptives (combined oral contraceptives, oestrogen-free pills with desogestrel, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUS)
Exclusion criteria : Comorbid obsessive-compulsive disorder (OCD), attention deficit/hyperactivity disorder (ADHD), depression, anxiety disorder when unstable or in need of an initial adjustment for a therapy Ongoing behavioural treatment for tics History of schizophrenia, psychotic, severe personality, or pervasive developmental disorder Patient has a history of suicidal ideation with intent to act or a plan to act in the 12 months preceding the Screening Visit Current clinical diagnosis of substance abuse or dependence and compulsive disorder 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 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 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 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 Positive urine pregnancy test Pregnancy or lactation period 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. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Nabiximols
Type of the intervention : Drug (including placebo)
Additional information about the intervention : oromucosal spray 1-12 puffs nabiximols / day, Duration of treatment: 13 weeks
Name(s) of the arm(s) associated with the given intervention : Experimental
Name of the intervention(*) : Placebo
Type of the intervention : Drug (including placebo)
Additional information about the intervention : oromucosal spray 1-12 puffs placebo / day, Duration of treatment: 13 weeks
Name(s) of the arm(s) associated with the given intervention : Placebo Comparator
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : YGTSS-TTS
Description of the outcome measure : Response-rate to treatment according to YGTSS-TTS (Total Tic-Score of the Yale Global Tic Severity Scale [YGTSS])
Type of the outcome measure : Primary
Time point(s) of assessment : 13 weeks
Name of the outcome measure(*) : Fitness to Drive Test
Description of the outcome measure : Reaction time and choice reaction (RT), Stress Behavior capacity (DT-Auslastung), Stress Behavior performance quantity (DT Mengenleistung), Concentration (COG), Perceptual speed (ATAVT)
Type of the outcome measure : Secondary
Time point(s) of assessment : 13 weeks
Name of the outcome measure(*) : YGTSS-TTS
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : YGTSS-TTS
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Baseline and 13 weeks
Name of the outcome measure(*) : Modified Rush Video-Based Tic Rating Scale (MRVS)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Clinical Global Impression-Improvement Score (CGI-I)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Clinical Global Impression-Severity Score (CGI-S)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Adult Tic Questionnaire (ATQ)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Tourette Syndrome-Quality of Life Scale (GTS-QoL)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Pre-monitory Urge for Tics Scale (PUTS)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Beck Depression Inventory-II (BDI-II)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Conners' Adult ADHD Rating Scale (CAARS)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Beck Anxiety Inventory (BAI)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Skala Impulsives-Verhalten-8 (I-8)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : 12-item short-form Health Survey (SF-12)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Rage Attacks Questionnaire for Adults with GTS (RAQ-GTS)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Name of the outcome measure(*) : Assessment of adverse events (AEs)
Description of the outcome measure : Not specified
Type of the outcome measure : Other
Time point(s) of assessment : through study completion, an average of 17 weeks
Name of the outcome measure(*) : Assessment of serious adverse events (SAEs)
Description of the outcome measure : Not specified
Type of the outcome measure : Other
Time point(s) of assessment : through study completion, an average of 17 weeks
Name of the outcome measure(*) : blood pressure
Description of the outcome measure : Not specified
Type of the outcome measure : Other
Time point(s) of assessment : through study completion, an average of 17 weeks
Name of the outcome measure(*) : pulse
Description of the outcome measure : Not specified
Type of the outcome measure : Other
Time point(s) of assessment : through study completion, an average of 17 weeks
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-3
Masking of intervention(s) assignment
Masking implemented? : true
Who is masked? : Participant, Investigator
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : Not specified

CANNA-TICS

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