CANNAbinoids in the Treatment of TICS (CANNA-TICS)

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Brief Title

CANNAbinoids in the Treatment of TICS (CANNA-TICS)

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Fitness to Drive Test

Condition

Tourette Syndrome

Intervention

nabiximols

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

98

Start Date

April 5, 2018

Completion Date

November 20, 2020

Primary Completion Date

November 20, 2020

Eligibility 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 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kirsten Müller-Vahl, MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT03087201

Organization ID

CANNA-TICS

Secondary IDs

2016-000564-42

Responsible Party

Sponsor

Study Sponsor

Hannover Medical School

Collaborators

 German Research Foundation

Study Sponsor

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


Verification Date

July 2020