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    Summary
    EudraCT Number:2016-000564-42
    Sponsor's Protocol Code Number:CANNA-TICS
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2017-02-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2016-000564-42
    A.3Full title of the trial
    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)
    Randomisierte, multizentrische, doppel-blinde, Placebo-kontrollierte Studie zum Nachweis der Wirksamkeit und Sicherheit von Nabiximols in der Behandlung von erwachsenen Patienten mit chronischen Tic-Störungen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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)
    A.4.1Sponsor's protocol code numberCANNA-TICS
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03087201
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHannover Medical School
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDeutsche Forschungsgemeinschaft (DFG)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy
    B.5.2Functional name of contact pointProf. Dr. Kirsten R. Müller-Vahl
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Neuberg-Straße 1
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number+495115323551
    B.5.5Fax number+495115323187
    B.5.6E-mailmueller-vahl.kirsten@mh-hannover.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sativex
    D.2.1.1.2Name of the Marketing Authorisation holderGW Pharma Ltd
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Oromucosal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdronabinol
    D.3.9.3Other descriptive nameDELTA-9-TETRAHYDROCANNABINOL
    D.3.9.4EV Substance CodeSUB27785
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCBD
    D.3.9.1CAS number 13956-29-1
    D.3.9.3Other descriptive nameCANNABIDIOL
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOromucosal spray, solution
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic tic disorders and Tourette syndrome
    E.1.1.1Medical condition in easily understood language
    Persistent neurobehavioural (=relationship between the action of the nervous system and behavior) disorders (chronic tic disorders and Tourette syndrome)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10043835
    E.1.2Term Tic disorders
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018269
    E.1.2Term Gilles de la Tourette syndrome
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal 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)
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Response to treatment according to YGTSS-TTS, defined as a reduction in YGTSS-TTS of at least 30% (compared to baseline) after 9 weeks of stable treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 9 weeks of stable treatment
    E.5.2Secondary end point(s)
    Key secondary endpoint: fitness to drive after 9 weeks of stable treatment as a binary criterion according to the Vienna Test System (a patient is fit to drive if none of the following tests has a percent rank below 16: Reaction time and choice reaction (RT), Stress Behavior capacity (DT-Auslastung), Stress Behavious performance quantity (DT_Mengenleistung), Concentration (COG), and Perceptual speed (ATAVT)).

    Further secondary endpoints: individual fitness to drive scores (RT, DT-Auslastung, DT-Mengenleistung, COG, ATAVT) after 9 weeks of stable treatment, YGTSS-TTS as a continuous endpoint (change from baseline) after 9 weeks of stable treatment.
    YGTSS-TTS as a binary responder criterion as well as a continuous endpoint after 4 weeks stable treatment and 1 month after end of treatment. The following efficacy endpoints will be assessed after 4 and 9 weeks stable treatment and 1 month after end of treatment: Yale Global Tic Severity Scale-Global Score (YGTSS-GS), modified Rush Video-Based Tic Rating Scale (MRVS), Clinical Global Impression–Improvement Score (CGI-I), Clinical Global Impression–Severity Score (CGI-S), Adult Tic Questionnaire (ATQ), Tourette syndrome-quality of life scale (GTS-QoL), Pre-monitory Urge for Tics Scale (PUTS), Beck Depression Inventory-II (BDI-II), Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Conners' Adult ADHD Rating Scale (CAARS), Beck Anxiety Inventory (BAI), Pittsburgh Sleep Quality Index (PSQI), Skala Impulsives-Verhalten-8 (I-8), 12-item short-form Health Survey (SF-12), and Rage attacks questionnaire for adults (RAQ).

    Assessment of safety:
    (Serious) adverse events (AEs/SAEs), blood pressure, and pulse at each visit. An independent Data Monitoring Committee (DMC) will be established.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key secondary endpoints:
    after 9 weeks of stable treatment

    Further secondary endpoints:
    after 9 weeks of stable treatment;
    after 4 weeks stable treatment and 1 month after end of treatment;
    after 4 and 9 weeks stable treatment and 1 month after end of treatment, respectively

    Assessment of safety:
    continuously at each visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state96
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After completion of the study, patients will be informed about available treatment strategies for tics including behavioral therapy, medical and surgical treatments. Patients will also be informed about treatment options with medicinal cannabis and cannabinoids including nabiximols and THC/dronabinol.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-01
    P. End of Trial
    P.End of Trial StatusRestarted
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