CANNAbinoids in the Treatment of TICS (CANNA-TICS)

NCT03087201 | Completed Phase 3 DMC

• 2 other identifiers: CANNA-TICS2016-000564-42
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 6

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.

Conditions

Tourette Syndrome; Tic Disorders

Keywords

Chronic tic disorders; Tourette syndrome

Outcome Measures

Primary Outcomes (1)

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

  13 weeks

Secondary Outcomes (22)

• Fitness to Drive Test

  13 weeks

• Fitness to Drive Test

  13 weeks

• Fitness to Drive Test

  13 weeks

• Fitness to Drive Test

  13 weeks

• Fitness to Drive Test

  13 weeks

Other Outcomes (4)

• Assessment of adverse events (AEs)

  through study completion, an average of 17 weeks

• Assessment of serious adverse events (SAEs)

  through study completion, an average of 17 weeks

• blood pressure

  through study completion, an average of 17 weeks

Study Arms (2)

nabiximols, oromucosal spray

EXPERIMENTAL

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

Drug: nabiximols

placebo, oromucosal spray

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

nabiximols DRUG

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

nabiximols, oromucosal spray

placebo DRUG

analogous to experimental intervention

placebo, oromucosal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• German Research Foundation: collaborator

Study Sites (6)

Uniklinik RWTH Aachen, Psychiatry and Psychotherapy

Aachen, Germany

Location

University Hospital Cologne, Psychiatry and Psychotherapy

Cologne, Germany

Location

University of Freiburg, Psychiatry and Psychotherapy

Freiburg im Breisgau, Germany

Location

Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy

Hanover, Germany

Location

University Hospital Schleswig-Holstein, Institute of Neurogenetics, Department of Pediatric and Adult Movement Disorders and Neuropsychiatrics

Lübeck, Germany

Location

LMU Munich, Psychiatry and Psychotherapy

Munich, Germany

Location

Related Publications (2)

• 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.

  PMID: 34708399 DERIVED

• Jakubovski 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.

  PMID: 33324255 DERIVED

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kirsten Müller-Vahl, MD

  Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 22, 2017
• Study Start: April 5, 2018
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)