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    Clinical Trial Results:
    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)

    Summary
    EudraCT number
    		 2016-000564-42
    Trial protocol
    		 DE  
    Global end of trial date
    20 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2023
    First version publication date
    31 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CANNA-TICS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03087201
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hannover Medical School
    Sponsor organisation address
    Carl-Neuberg-Str. 1, Hannover, Germany, 30625
    Public contact
    Zentrum für Klinische Forschung (ZKS), Hannover Medical School, EudraCT@mh-hannover.de
    Scientific contact
    Zentrum für Klinische Forschung (ZKS), Hannover Medical School, EudraCT@mh-hannover.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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
    Protection of trial subjects
    The clinical trial was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and with the standards of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP). A continuous risk assessment was performed during the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 97
    Worldwide total number of subjects
    97
    EEA total number of subjects
    97
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    97
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 98 adult patients with chronic tic disorders (Tourette Syndrom (TS) or other chronic tic disorders) were recruited across 6 centers throughout Germany

    Pre-assignment
    Screening details
    		 Eligibility will be determined based upon the inclusion and exclusion criteria

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nabiximol arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nabiximol
    Investigational medicinal product code
    Other name
    Sativex
    Pharmaceutical forms
    Sublingual spray
    Routes of administration
    Sublingual use
    Dosage and administration details
    1-12 puffs/day; 1 puff = 100 μl spray = 2.7 mg THC and 2.5 mg cannabidiol (CBD)), oromucosal spray. Nabiximols (Sativex®) is a plant extract from Cannabis sativa L. It is a sublingually administered oromucosal spray that contains THC and CBD at about a 1:1 ratio.

    Arm title
    		 Placebo arm
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sativex placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sublingual spray
    Routes of administration
    Subgingival use
    Dosage and administration details
    Placebo (1-12 puffs/day; 1 puff = 100 μl spray), oromucosal spray.

    Number of subjects in period 1
    		Nabiximol arm Placebo arm
    Started
    64
    33
    Completed
    48
    24
    Not completed
    16
    9
         Consent withdrawn by subject
    6
    2
         Physician decision
    1
    1
         other reasons
    2
    1
         Adverse event, non-fatal
    5
    1
         patient was deblinded during study
    2
    -
         deblinded patient
    -
    3
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nabiximol arm
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Reporting group values
    		 Nabiximol arm Placebo arm Total
    Number of subjects
    		 64 33 97
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 64 33 97
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 15 9 24
        Male
    		 49 24 73

    End points

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    End points reporting groups
    Reporting group title
    Nabiximol arm
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Primary: primary response >25% in YGTSS-TTS

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    End point title
    		 primary response >25% in YGTSS-TTS
    End point description
    Response to treatment according to YGTSS-TTS, defined as a reduction in YGTSS-TTS of at least 25% (compared to baseline) after 9 weeks of stable treatment.
    End point type
    Primary
    End point timeframe
    9 weeks of stable treatment
    End point values
    		 Nabiximol arm Placebo arm
    Number of subjects analysed
    64
    33
    Units: subjects
    14
    3
    Statistical analysis title
    		 Primary response > 25%
    Statistical analysis description
    Primary response > 25% (as determined in blind review) ITT
    Comparison groups
    Placebo arm v Nabiximol arm
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0755
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Mantel-Haenszel estimate
    Point estimate
    -0.1278
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2688
         upper limit
    		 0.0131

    Primary: Primary response > 30%

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    End point title
    		 Primary response > 30%
    End point description
    Response to treatment according to YGTSS-TTS, defined as a reduction in YGTSS-TTS of at least 25% (compared to baseline) after 9 weeks of stable treatment.
    End point type
    Primary
    End point timeframe
    9 weeks of stable treatment
    End point values
    		 Nabiximol arm Placebo arm
    Number of subjects analysed
    64
    33
    Units: subjects
    8
    1
    Statistical analysis title
    		 Primary response > 30%
    Comparison groups
    Nabiximol arm v Placebo arm
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0633
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Mantel-Haenszel estimate
    Point estimate
    -0.0947
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1946
         upper limit
    		 0.0052

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse event documentation period for this trial begins upon first administration of the IMP(s) and ends with the last follow-up visit.
    Adverse event reporting additional description
    Numbers in the non-serious adverse events section reflect all adverse events occurring during the study (non-serious and serious).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Nabiximols
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Nabiximols
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 64 (1.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Social circumstances
    Pregnancy Of Partner
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Tic
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Nabiximols
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 33 (78.79%)
    61 / 64 (95.31%)
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    3
    Hypertension
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    Dental implantation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Nasal septal operation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Tooth extraction
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Sluggishness
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 64 (4.69%)
         occurrences all number
    0
    3
    Application site dryness
         subjects affected / exposed
    3 / 33 (9.09%)
    12 / 64 (18.75%)
         occurrences all number
    3
    12
    Application site dysaesthesia
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 64 (3.13%)
         occurrences all number
    2
    2
    Application site hypoaesthesia
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Application site irritation
         subjects affected / exposed
    3 / 33 (9.09%)
    5 / 64 (7.81%)
         occurrences all number
    3
    5
    Application site pain
         subjects affected / exposed
    2 / 33 (6.06%)
    3 / 64 (4.69%)
         occurrences all number
    2
    3
    Application site paraesthesia
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Asthenia
         subjects affected / exposed
    1 / 33 (3.03%)
    8 / 64 (12.50%)
         occurrences all number
    1
    11
    Chest pain
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Condition aggravated
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 64 (4.69%)
         occurrences all number
    0
    3
    Crying
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Facial pain
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    8 / 33 (24.24%)
    19 / 64 (29.69%)
         occurrences all number
    12
    20
    Feeling abnormal
         subjects affected / exposed
    1 / 33 (3.03%)
    26 / 64 (40.63%)
         occurrences all number
    1
    35
    Feeling cold
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Feeling drunk
         subjects affected / exposed
    0 / 33 (0.00%)
    4 / 64 (6.25%)
         occurrences all number
    0
    4
    Feeling hot
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    2
    Feeling jittery
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Feeling of relaxation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Glassy eyes
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Hunger
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Influenza like illness
         subjects affected / exposed
    4 / 33 (12.12%)
    4 / 64 (6.25%)
         occurrences all number
    4
    4
    Malaise
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Pre-existing condition improved
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Sense of oppression
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Application site discomfort
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 64 (4.69%)
         occurrences all number
    0
    3
    Social circumstances
    Pregnancy of partner
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Sexual dysfunction
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Tonsillar inflammation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    2
    Pneumonitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Panic disorder
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Panic attack
         subjects affected / exposed
    1 / 33 (3.03%)
    4 / 64 (6.25%)
         occurrences all number
    2
    4
    Nervousness
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    2
    0
    Mood swings
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Aggression
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Agitation
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Apathy
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Confusional state
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Daydreaming
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Depressed mood
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 64 (4.69%)
         occurrences all number
    0
    3
    Depression
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Dysphemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Euphoric mood
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Fear of disease
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Impulsive behaviour
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Indifference
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Initial insomnia
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Insomnia
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 64 (1.56%)
         occurrences all number
    1
    2
    Irritability
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Libido decreased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Libido increased
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Middle insomnia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Mood altered
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Thought blocking
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Stress
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Restlessness
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Psychomotor retardation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Time perception altered
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Road traffic accident
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Congenital, familial and genetic disorders
    Tourette's disorder
         subjects affected / exposed
    4 / 33 (12.12%)
    4 / 64 (6.25%)
         occurrences all number
    5
    6
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 33 (0.00%)
    5 / 64 (7.81%)
         occurrences all number
    0
    5
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    2 / 33 (6.06%)
    2 / 64 (3.13%)
         occurrences all number
    4
    3
    Taste disorder
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Sensory disturbance
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Muscle contractions involuntary
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Memory impairment
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    3
    Loss of consciousness
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    7 / 33 (21.21%)
    9 / 64 (14.06%)
         occurrences all number
    9
    10
    Disturbance in attention
         subjects affected / exposed
    2 / 33 (6.06%)
    6 / 64 (9.38%)
         occurrences all number
    3
    6
    Head discomfort
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Fumbling
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    11 / 33 (33.33%)
    23 / 64 (35.94%)
         occurrences all number
    12
    33
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 64 (4.69%)
         occurrences all number
    0
    3
    Visual impairment
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Vision blurred
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    4
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    3 / 33 (9.09%)
    5 / 64 (7.81%)
         occurrences all number
    4
    5
    Toothache
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Faeces soft
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Eructation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 64 (4.69%)
         occurrences all number
    0
    4
    Defaecation urgency
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Abnormal faeces
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 64 (3.13%)
         occurrences all number
    1
    2
    Abdominal distension
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Bladder irritation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 64 (0.00%)
         occurrences all number
    3
    0
    Back pain
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Fibromyalgia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    2
    Muscle spasms
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Muscle twitching
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Nuchal rigidity
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Pain in jaw
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Abscess
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 64 (4.69%)
         occurrences all number
    1
    3
    Gastrointestinal infection
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 33 (12.12%)
    9 / 64 (14.06%)
         occurrences all number
    5
    10
    Oral herpes
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 64 (3.13%)
         occurrences all number
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 64 (3.13%)
         occurrences all number
    1
    2
    Feeding intolerance
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Food craving
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 64 (4.69%)
         occurrences all number
    0
    3
    Increased appetite
         subjects affected / exposed
    2 / 33 (6.06%)
    3 / 64 (4.69%)
         occurrences all number
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2017
    Revision of study protocol: i.a. implementation of the study part ‘fitness to drive`
    22 Nov 2017
    Application for resumption of recruitment after temporary halt
    19 Mar 2019
    Revision of study protocol: i.a. alteration in manufacturing chain, extension duration of recruitment

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    12 Jun 2018
    due to defective label
    08 Aug 2018

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36878177
    http://www.ncbi.nlm.nih.gov/pubmed/36213751
    http://www.ncbi.nlm.nih.gov/pubmed/33594741
    http://www.ncbi.nlm.nih.gov/pubmed/33324255
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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