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    Clinical Trial Results:
    A randomized, subject- and Investigator-blinded, placebo-controlled, parallel-group study to investigate whether AFQ056 reduces cocaine use in patients diagnosed with Cocaine Use Disorder (CUD)

    Summary
    EudraCT number
    		 2017-000736-33
    Trial protocol
    		 ES  
    Global end of trial date
    16 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2020
    First version publication date
    31 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAFQ056X2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03242928
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG  , 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG  , 41 613241111, Novartis.email@Novartis.com
    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
    16 Dec 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate treatment effect of 98-day mavoglurant administration in reducing cocaine us
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Dec 2017
    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
    Argentina: 37
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    Switzerland: 16
    Worldwide total number of subjects
    68
    EEA total number of subjects
    15
    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)
    68
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 There were 71 patients randomized but 3 patients did not receive study treatment

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AFQ056
    Arm description
    		 Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mavoglurant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Mavoglurant: up-titration bid regimen followed by fixed-dose bid regimen (50 mg bid from Day 1 to Day 7 followed by 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days)

    Arm title
    		 Placebo
    Arm description
    		 Matching tablet of placebo taken orally BID
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo doses and regimen to AFQ056 arm

    Number of subjects in period 1
    		AFQ056 Placebo
    Started
    31
    37
    Completed
    22
    32
    Not completed
    9
    5
         Consent withdrawn by subject
    5
    3
         Physician decision
    -
    1
         Adverse event, non-fatal
    2
    1
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AFQ056
    Reporting group description
    		 Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days

    Reporting group title
    Placebo
    Reporting group description
    		 Matching tablet of placebo taken orally BID

    Reporting group values
    		 AFQ056 Placebo Total
    Number of subjects
    		 31 37 68
    Age Categorical
    Units: participants
        18 - 65 years
    		 31 37 68
    Sex: Female, Male
    Units:
        Female
    		 5 7 12
        Male
    		 26 30 56
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 0 1 1
        White
    		 31 36 67

    End points

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    End points reporting groups
    Reporting group title
    AFQ056
    Reporting group description
    		 Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days

    Reporting group title
    Placebo
    Reporting group description
    		 Matching tablet of placebo taken orally BID

    Primary: Proportion of cocaine use days

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    End point title
    		 Proportion of cocaine use days
    End point description
    The cocaine consumption was recorded once daily (Yes/No) by the subject using the Timeline Follow-Back (TLFB) cocaine assessment tool during the treatment period. For each patient, the proportion of cocaine use days was calculated by dividing the number of days of cocaine use during the treatment period, i.e. 98 days for completers and number of days between Day 1 and day of last dose in case of premature discontinuation of study treatment.
    End point type
    Primary
    End point timeframe
    Day 1 up to day 98
    End point values
    		 AFQ056 Placebo
    Number of subjects analysed
    29
    36
    Units: cocaine use days
        arithmetic mean (standard error)
    0.122 ( 0.027 )
    0.209 ( 0.024 )
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    Placebo v AFQ056
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.021
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.087
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.161
         upper limit
    		 -0.013
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.037

    Secondary: Proportion of positive urine measuremebnts of benzoylecgonine (BE)

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    End point title
    		 Proportion of positive urine measuremebnts of benzoylecgonine (BE)
    End point description
    Urine samples were analyzed for the presence of cocaine's metabolite benzoylecgonine (BE) which is the main metabolite of cocaine present in urine. Two urine samples were provided per week to provide a quantitative measure.
    End point type
    Secondary
    End point timeframe
    Day 1 up to day 98
    End point values
    		 AFQ056 Placebo
    Number of subjects analysed
    29
    36
    Units: positive urine samples
        arithmetic mean (standard error)
    0.666 ( 0.057 )
    0.843 ( 0.051 )
    Statistical analysis title
    		 ANOVA analysis
    Comparison groups
    AFQ056 v Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.025
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.177
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.331
         upper limit
    		 -0.023
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.077

    Secondary: Proportion of days of alcohol consumption

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    End point title
    		 Proportion of days of alcohol consumption
    End point description
    Alcohol consumption was recorded by the subjects using the Timeline Follow-Back (TLFB) alcohol self report. The number of standard drinks were recorded daily. The proportion of days of alcohol consumption during the study treatment period was was compared using an ANCOVA model with treatment as factor and past alcohol consumption as covariate. The past consumption of alcohol was the proportion of alcohol over the 28 days preceding the screening visit, which was assessed retrospectively using the TLFB.
    End point type
    Secondary
    End point timeframe
    Day 1 up to day 98
    End point values
    		 AFQ056 Placebo
    Number of subjects analysed
    29
    36
    Units: alcohol consumption days
        arithmetic mean (standard error)
    0.233 ( 0.030 )
    0.303 ( 0.026 )
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    AFQ056 v Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.072
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.146
         upper limit
    		 0.006
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.038

    Secondary: AFQ056 plasma concentrations

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    End point title
    		 AFQ056 plasma concentrations [1]
    End point description
    Plasma samples were collected to assess pharmacokinetics (PK)
    End point type
    Secondary
    End point timeframe
    Day 15 (0h, 2h), Day 29 (0, 2h), Day 57 (0h, 2h), Day 98 (0h,2h)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No analysis done
    End point values
    		 AFQ056
    Number of subjects analysed
    29
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 15 0 hour, n=21
    41.2 ( 47.4 )
        Day 15 2 hour,,n=21
    78.0 ( 91.7 )
        Day 29 0 hour, n=26
    83.5 ( 116 )
        Day 29 2 hour,,n=24
    148 ( 131 )
        Day 57 0 hour, n=22
    108 ( 153 )
        Day 57 2 hour, n=22
    141 ( 153 )
        Day 98 0 hour, n=21
    89.8 ( 148 )
        Day 98 2 hour, n=21
    116 ( 86.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    AFQ056
    Reporting group description
    		 Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days

    Reporting group title
    Placebo
    Reporting group description
    		 Matching tablet of placebo taken orally BID

    Serious adverse events
    		 AFQ056 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         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
    		 AFQ056 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 31 (83.87%)
    30 / 37 (81.08%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Peripheral coldness
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Vasospasm
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 37 (2.70%)
         occurrences all number
    1
    1
    Discomfort
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 31 (6.45%)
    3 / 37 (8.11%)
         occurrences all number
    4
    3
    Influenza like illness
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 37 (2.70%)
         occurrences all number
    4
    1
    Pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Physical deconditioning
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 37 (2.70%)
         occurrences all number
    1
    1
    Thirst
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Vessel puncture site pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Pelvic pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 37 (2.70%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Nasal congestion
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Nasal mucosal ulcer
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 37 (2.70%)
         occurrences all number
    2
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 31 (9.68%)
    4 / 37 (10.81%)
         occurrences all number
    4
    5
    Aversion
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Depressed mood
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 37 (5.41%)
         occurrences all number
    1
    3
    Depression
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Depressive symptom
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Disorientation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    2
    Euphoric mood
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Feeling guilty
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Hallucination
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Hallucination, auditory
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Hallucination, olfactory
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Hallucination, visual
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Ideas of reference
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Illusion
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Initial insomnia
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Insomnia
         subjects affected / exposed
    5 / 31 (16.13%)
    2 / 37 (5.41%)
         occurrences all number
    9
    11
    Irritability
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Nightmare
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Paranoia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 37 (0.00%)
         occurrences all number
    4
    0
    Stress
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 37 (5.41%)
         occurrences all number
    2
    3
    Amylase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Blood creatinine abnormal
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 37 (5.41%)
         occurrences all number
    3
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 37 (2.70%)
         occurrences all number
    1
    2
    Lymphocyte count increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Platelet count increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Red blood cell count increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 37 (2.70%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Limb injury
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Road traffic accident
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Skin abrasion
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Skin laceration
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Toxicity to various agents
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 31 (22.58%)
    4 / 37 (10.81%)
         occurrences all number
    17
    4
    Headache
         subjects affected / exposed
    6 / 31 (19.35%)
    10 / 37 (27.03%)
         occurrences all number
    13
    24
    Muscle contractions involuntary
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Resting tremor
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 37 (2.70%)
         occurrences all number
    4
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Monocytosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Diplopia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Photopsia
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Photophobia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    3 / 31 (9.68%)
    7 / 37 (18.92%)
         occurrences all number
    6
    12
    Constipation
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    2 / 31 (6.45%)
    5 / 37 (13.51%)
         occurrences all number
    3
    5
    Dyspepsia
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 37 (5.41%)
         occurrences all number
    3
    2
    Dry mouth
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 37 (0.00%)
         occurrences all number
    4
    0
    Gingival bleeding
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    6 / 31 (19.35%)
    3 / 37 (8.11%)
         occurrences all number
    8
    3
    Odynophagia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia oral
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Regurgitation
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    0 / 31 (0.00%)
    6 / 37 (16.22%)
         occurrences all number
    0
    6
    Vomiting
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 37 (2.70%)
         occurrences all number
    6
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    2
    Hyperhidrosis
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 37 (2.70%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 37 (0.00%)
         occurrences all number
    7
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Nocturia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Renal pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 31 (12.90%)
    5 / 37 (13.51%)
         occurrences all number
    4
    6
    Muscle tightness
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Muscle twitching
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 37 (2.70%)
         occurrences all number
    1
    1
    Rhabdomyolysis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Hordeolum
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    4 / 31 (12.90%)
    2 / 37 (5.41%)
         occurrences all number
    7
    2
    Laryngitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 31 (6.45%)
    8 / 37 (21.62%)
         occurrences all number
    2
    10
    Pharyngitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Nov 2017
    The protocol was amended in response to the request from the Swiss Ethics Committee to exclude patients with controlled hypertension. In addition, this protocol amendment introduced the possibility of performing central and local BE analysis for inclusion, in order to optimize sampling results turnaround time.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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