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 (CANNA-TICS)

Phase 1

• Conditions: Chronic tic disorders and Tourette syndrome; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; MedDRA version: 20.0 Level: HLT Classification code 10043835 Term: Tic disorders System Organ Class: 100000004873; MedDRA version: 20.0 Level: LLT Classification code 10018269 Term: Gilles de la Tourette syndrome System Organ Class: 100000004850

• Registration Number: EUCTR2016-000564-42-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-20
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

1.Chronic tic disorder or Tourette syndrome according to DSM-5
2.Age =18 years
3.YGTSS-TTS > 14 for patients with Tourette syndrome or YGTSS-TTS > 10 for patients with chronic motor or vocal tics only (= CTD)
4.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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 88
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1.One of the following conditions when unstable or in need of an initial adjustment for a therapy: Comorbid OCD, ADHD, depression, and anxiety disorder
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 CBM in the 30-day period prior to study entry and/or positive 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified