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CANNAbinoids in the Treatment of TICS (CANNA-TICS)

Sponsor
Hannover Medical School (Other)
Overall Status
Completed
CT.gov ID
NCT03087201
Collaborator
German Research Foundation (Other)
98
Enrollment
6
Locations
2
Arms
31.5
Actual Duration (Months)
16.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 5, 2018
Actual Primary Completion Date :
Nov 20, 2020
Actual Study Completion Date :
Nov 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: nabiximols, oromucosal spray

1-12 puffs nabiximols / day, Duration of treatment: 13 weeks

Drug: nabiximols
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
Placebo Comparator: placebo, oromucosal spray

1-12 puffs placebo / day, Duration of treatment: 13 weeks

Drug: placebo
analogous to experimental intervention

Outcome Measures

Primary Outcome Measures

  1. Response-rate to treatment according to YGTSS-TTS (Total Tic-Score of the Yale Global Tic Severity Scale [YGTSS]) [13 weeks]

Secondary Outcome Measures

  1. Fitness to Drive Test [13 weeks]

    Reaction time and choice reaction (RT)

  2. Fitness to Drive Test [13 weeks]

    Stress Behavior capacity (DT-Auslastung)

  3. Fitness to Drive Test [13 weeks]

    Stress Behavior performance quantity (DT Mengenleistung)

  4. Fitness to Drive Test [13 weeks]

    Concentration (COG)

  5. Fitness to Drive Test [13 weeks]

    Perceptual speed (ATAVT)

  6. YGTSS-TTS [8 weeks and 1 month after end of treatment (17 weeks)]

  7. YGTSS-TTS [Baseline and 13 weeks]

  8. YGTSS-Global Score (YGTSS-GS) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  9. Modified Rush Video-Based Tic Rating Scale (MRVS) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  10. Clinical Global Impression-Improvement Score (CGI-I) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  11. Clinical Global Impression-Severity Score (CGI-S) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  12. Adult Tic Questionnaire (ATQ) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  13. Tourette Syndrome-Quality of Life Scale (GTS-QoL) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  14. Pre-monitory Urge for Tics Scale (PUTS) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  15. Beck Depression Inventory-II (BDI-II) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  16. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  17. Conners' Adult ADHD Rating Scale (CAARS) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  18. Beck Anxiety Inventory (BAI) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  19. Pittsburgh Sleep Quality Index (PSQI) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  20. Skala Impulsives-Verhalten-8 (I-8) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  21. 12-item short-form Health Survey (SF-12) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

  22. Rage Attacks Questionnaire for Adults with GTS (RAQ-GTS) [8 weeks, 13 weeks and 1 month after end of treatment (17 weeks)]

Other Outcome Measures

  1. Assessment of adverse events (AEs) [through study completion, an average of 17 weeks]

  2. Assessment of serious adverse events (SAEs) [through study completion, an average of 17 weeks]

  3. blood pressure [through study completion, an average of 17 weeks]

  4. pulse [through study completion, an average of 17 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Chronic tic disorder or Tourette syndrome according to DSM-5

  2. Age ≥18 years

  3. 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)

  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 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

  • < 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:

  1. 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

  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 cannabinoid-based medicine (CBM) in the 30-day period prior to study entry and/or positive delta-9-tetrahydrocannabinol (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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uniklinik RWTH Aachen, Psychiatry and Psychotherapy Aachen Germany
2 University Hospital Cologne, Psychiatry and Psychotherapy Cologne Germany
3 University of Freiburg, Psychiatry and Psychotherapy Freiburg Germany
4 Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy Hannover Germany
5 University Hospital Schleswig-Holstein, Institute of Neurogenetics, Department of Pediatric and Adult Movement Disorders and Neuropsychiatrics Luebeck Germany
6 LMU Munich, Psychiatry and Psychotherapy Munich Germany

Sponsors and Collaborators

  • Hannover Medical School
  • German Research Foundation

Investigators

  • Principal Investigator: Kirsten Müller-Vahl, MD, Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT03087201
Other Study ID Numbers:
  • CANNA-TICS
  • 2016-000564-42
First Posted:
Mar 22, 2017
Last Update Posted:
Dec 10, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hannover Medical School
Chronic tic disorders
Tourette syndrome
Additional relevant MeSH terms:
Tourette Syndrome
Tics
Tic Disorders
Nabiximols

Study Results

No Results Posted as of Dec 10, 2020