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CANNAbinoids in the Treatment of TICS (CANNA-TICS) (CANNA-TICS)

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ClinicalTrials.gov Identifier: NCT03087201
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Hannover Medical School

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
Tourette Syndrome Tic Disorders Drug: nabiximols Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 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 : April 5, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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




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

Secondary Outcome Measures :
  1. YGTSS-TTS [ Time Frame: Baseline and 13 weeks ]
  2. YGTSS-TTS [ Time Frame: 8 weeks and 1 month after end of treatment (17 weeks) ]
  3. YGTSS-Global Score (YGTSS-GS) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  4. Modified Rush Video-Based Tic Rating Scale (MRVS) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  5. Clinical Global Impression-Improvement Score (CGI-I) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  6. Clinical Global Impression-Severity Score (CGI-S) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  7. Adult Tic Questionnaire (ATQ) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  8. Tourette Syndrome-Quality of Life Scale (GTS-QoL) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  9. Pre-monitory Urge for Tics Scale (PUTS) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  10. Beck Depression Inventory-II (BDI-II) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  11. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  12. Conners' Adult ADHD Rating Scale (CAARS) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  13. Beck Anxiety Inventory (BAI) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  14. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  15. Skala Impulsives-Verhalten-8 (I-8) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  16. 12-item short-form Health Survey (SF-12) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]
  17. Rage Attacks Questionnaire for Adults with GTS (RAQ-GTS) [ Time Frame: 8 weeks, 13 weeks and 1 month after end of treatment (17 weeks) ]

Other Outcome Measures:
  1. Assessment of adverse events (AEs) [ Time Frame: through study completion, an average of 17 weeks ]
  2. Assessment of serious adverse events (SAEs) [ Time Frame: through study completion, an average of 17 weeks ]
  3. blood pressure [ Time Frame: through study completion, an average of 17 weeks ]
  4. pulse [ Time Frame: through study completion, an average of 17 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 and oestrogen-free pills with desogestrel, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUS) or a barrier method, e.g. condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam, gel, film, cream or suppository)
  • 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 and oestrogen-free pills with desogestrel, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUS) or a barrier method, e.g. condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam, gel, film, cream or suppository)

Exclusion Criteria:

  1. Comorbid obsessive-compulsive disorder (OCD), attention deficit/hyperactivity disorder (ADHD), depression, anxiety disorder when unstable and/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. Current clinical diagnosis of substance abuse or dependence and compulsive disorder
  5. 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
  6. 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
  7. 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
  8. 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
  9. Positive urine pregnancy test
  10. Pregnancy or lactation period
  11. 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.
  12. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087201


Contacts
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Contact: Kirsten Müller-Vahl, MD +49 511 532 ext 3551 mueller-vahl.kirsten@mh-hannover.de

Locations
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Germany
Uniklinik RWTH Aachen, Psychiatry and Psychotherapy Recruiting
Aachen, Germany
Contact: Irene Neuner, Prof. Dr.         
University Hospital Cologne, Psychiatry and Psychotherapy Recruiting
Cologne, Germany
Contact: Daniel Huys, Dr.         
University of Freiburg, Psychiatry and Psychotherapy Recruiting
Freiburg, Germany
Contact: Ludger Tebartz van Elst, Prof. Dr.         
Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy Recruiting
Hannover, Germany
Contact: Kirsten Mueller-Vahl, Prof. Dr.         
University Hospital Schleswig-Holstein, Institute of Neurogenetics, Department of Pediatric and Adult Movement Disorders and Neuropsychiatrics Recruiting
Luebeck, Germany
Contact: Alexander Muenchau, Prof. Dr.         
LMU Munich, Psychiatry and Psychotherapy Recruiting
Munich, Germany
Contact: Richard Musil, Dr.         
Sponsors and Collaborators
Hannover Medical School
German Research Foundation
Investigators
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Principal Investigator: Kirsten Müller-Vahl, MD Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy

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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT03087201     History of Changes
Other Study ID Numbers: CANNA-TICS
2016-000564-42 ( EudraCT Number )
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Tourette Syndrome
Tics
Tic Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Nabiximols
Dronabinol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones