Tourette SyndromePhase 3CANNA-TICSNCT03087201
CANNAbinoids in the Treatment of TICS (CANNA-TICS)
A Phase 3 study testing nabiximols in people with Tourette Syndrome and Tic Disorders, run by Hannover Medical School at 6 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourette Syndrome, Tic Disorders
- What is being tested?
- nabiximols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 6 sitesGermany
- Study dates
- 5 Apr 2018to 20 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Uniklinik RWTH Aachen, Psychiatry and Psychotherapy
Aachen
University Hospital Cologne, Psychiatry and Psychotherapy
Cologne
University of Freiburg, Psychiatry and Psychotherapy
Freiburg im Breisgau
Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy
Hanover
University Hospital Schleswig-Holstein, Institute of Neurogenetics, Department of Pediatric and Adult Movement Disorders and Neuropsychiatrics
Lübeck
LMU Munich, Psychiatry and Psychotherapy
Munich
About this study
Official title: 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
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.
- Conditions
- Tourette Syndrome, Tic Disorders
- Being tested
- nabiximols, placebo
- Keywords
- Chronic tic disorders, Tourette syndrome
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nabiximolsDrug
starting dose (1 puff): 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD), maximum dose (12 puffs): 32.4 mg THC/30 mg CBD, no target dose is defined
Duration of treatment: 13 weeks
placeboDrug
analogous to experimental intervention
| Study group | Role | What they receive |
|---|---|---|
| nabiximols, oromucosal spray | Experimental | 1-12 puffs nabiximols / day, Duration of treatment: 13 weeks Receives: Drug: nabiximols |
| placebo, oromucosal spray | Placebo comparator | 1-12 puffs placebo / day, Duration of treatment: 13 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response-rate to treatment according to YGTSS-TTS (Total Tic-Score of the Yale Global Tic Severity Scale [YGTSS])
Measured: 13 weeks
Secondary outcomes (22)
Fitness to Drive Test
Reaction time and choice reaction (RT)
Measured: 13 weeks
Fitness to Drive Test
Stress Behavior capacity (DT-Auslastung)
Measured: 13 weeks
Fitness to Drive Test
Stress Behavior performance quantity (DT Mengenleistung)
Measured: 13 weeks
Fitness to Drive Test
Concentration (COG)
Measured: 13 weeks
Fitness to Drive Test
Perceptual speed (ATAVT)
Measured: 13 weeks
YGTSS-TTS
Measured: 8 weeks and 1 month after end of treatment (17 weeks)
YGTSS-TTS
Measured: Baseline and 13 weeks
YGTSS-Global Score (YGTSS-GS)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Modified Rush Video-Based Tic Rating Scale (MRVS)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Clinical Global Impression-Improvement Score (CGI-I)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Clinical Global Impression-Severity Score (CGI-S)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Adult Tic Questionnaire (ATQ)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Tourette Syndrome-Quality of Life Scale (GTS-QoL)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Pre-monitory Urge for Tics Scale (PUTS)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Beck Depression Inventory-II (BDI-II)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Conners' Adult ADHD Rating Scale (CAARS)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Beck Anxiety Inventory (BAI)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Pittsburgh Sleep Quality Index (PSQI)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Skala Impulsives-Verhalten-8 (I-8)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
12-item short-form Health Survey (SF-12)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Rage Attacks Questionnaire for Adults with GTS (RAQ-GTS)
Measured: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start5 Apr 2018
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Kirsten Müller-Vahl, MD, Principal investigator, Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087201
- Sponsor's protocol ID
- CANNA-TICS
- Other IDs
- 2016-000564-42, 2016
- Acronym
- CANNA-TICS
- Status last verified
- Jul 2020
- First submitted
- 6 Mar 2017
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szejko N, Saramak K, Lombroso A, Muller-Vahl K. Cannabis-based medicine in treatment of patients with Gilles de la Tourette syndrome. Neurol Neurochir Pol. 2022;56(1):28-38. doi: 10.5603/PJNNS.a2021.0081. Epub 2021 Oct 28.
PubMed 34708399Jakubovski E, Pisarenko A, Fremer C, Haas M, May M, Schumacher C, Schindler C, Hackl S, Aguirre Davila L, Koch A, Brunnauer A, Cimpianu CL, Lutz B, Bindila L, Muller-Vahl K. The CANNA-TICS Study Protocol: A Randomized Multi-Center Double-Blind Placebo Controlled Trial to Demonstrate the Efficacy and Safety of Nabiximols in the Treatment of Adults With Chronic Tic Disorders. Front Psychiatry. 2020 Nov 26;11:575826. doi: 10.3389/fpsyt.2020.575826. eCollection 2020.
PubMed 33324255
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03087201
- Acronym / sponsor ID
- CANNA-TICS / CANNA-TICS
- Conditions
- Tourette Syndrome, Tic Disorders
- Keywords
- Chronic tic disorders, Tourette syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nabiximols, oromucosal spray | Experimental | Drug: nabiximols1-12 puffs nabiximols / day, Duration of treatment: 13 weeks |
| placebo, oromucosal spray | Placebo comparator | Drug: placebo1-12 puffs placebo / day, Duration of treatment: 13 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nabiximolsstarting dose (1 puff): 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD), maximum dose (12 puffs): 32.4 mg THC/30 mg CBD, no target dose is defined Duration of treatment: 13 weeks | Drug | nabiximols, oromucosal spray |
| placeboanalogous to experimental intervention | Drug | placebo, oromucosal spray |
Primary outcome
Response-rate to treatment according to YGTSS-TTS (Total Tic-Score of the Yale Global Tic Severity Scale [YGTSS])
Time frame: 13 weeks
22 secondary outcomes
Fitness to Drive Test
Time frame: 13 weeks
Fitness to Drive Test
Time frame: 13 weeks
Fitness to Drive Test
Time frame: 13 weeks
Fitness to Drive Test
Time frame: 13 weeks
Fitness to Drive Test
Time frame: 13 weeks
YGTSS-TTS
Time frame: 8 weeks and 1 month after end of treatment (17 weeks)
YGTSS-TTS
Time frame: Baseline and 13 weeks
YGTSS-Global Score (YGTSS-GS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Modified Rush Video-Based Tic Rating Scale (MRVS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Clinical Global Impression-Improvement Score (CGI-I)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Clinical Global Impression-Severity Score (CGI-S)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Adult Tic Questionnaire (ATQ)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Tourette Syndrome-Quality of Life Scale (GTS-QoL)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Pre-monitory Urge for Tics Scale (PUTS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Beck Depression Inventory-II (BDI-II)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Conners' Adult ADHD Rating Scale (CAARS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Beck Anxiety Inventory (BAI)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Skala Impulsives-Verhalten-8 (I-8)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
12-item short-form Health Survey (SF-12)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Rage Attacks Questionnaire for Adults with GTS (RAQ-GTS)
Time frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Derived from this study: PubMed 34708399Szejko N, Saramak K, Lombroso A, Muller-Vahl K. Cannabis-based medicine in treatment of patients with Gilles de la Tourette syndrome. Neurol Neurochir Pol. 2022;56(1):28-38. doi: 10.5603/PJNNS.a2021.0081. Epub 2021 Oct 28.
- Derived from this study: PubMed 33324255Jakubovski E, Pisarenko A, Fremer C, Haas M, May M, Schumacher C, Schindler C, Hackl S, Aguirre Davila L, Koch A, Brunnauer A, Cimpianu CL, Lutz B, Bindila L, Muller-Vahl K. The CANNA-TICS Study Protocol: A Randomized Multi-Center Double-Blind Placebo Controlled Trial to Demonstrate the Efficacy and Safety of Nabiximols in the Treatment of Adults With Chronic Tic Disorders. Front Psychiatry. 2020 Nov 26;11:575826. doi: 10.3389/fpsyt.2020.575826. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Müller-Vahl, MD principal investigator
Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nabiximols in people with Tourette Syndrome and Tic Disorders, run by Hannover Medical School at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response-rate to treatment according to YGTSS-TTS (Total Tic-Score of the Yale Global Tic Severity Scale [YGTSS]) (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03087201, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.