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    Clinical Trial Results:
    An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson's patients with L-dopa induced dyskinesias

    Summary
    EudraCT number
    2011-004378-27
    Trial protocol
    ES   HU   DE   IT   SK   AT  
    Global end of trial date
    04 Nov 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    01 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAFQ056A2299
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01491932
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002 , Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111 ,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111 ,
    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
    04 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of AFQ056 in patients with PD-LID as assessed by •Incidence and severity of adverse events and serious adverse events •Changes in vital signs, laboratory assessments, and ECGs •Changes in underlying symptoms of PD as measured by the UPDRS (Unified Parkinson's Disease Rating Scale) part III (Motor Examination) and AEs potentially related to an exacerbation of the movement disorder of PD
    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
    09 Mar 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 32
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 33
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Italy: 28
    Country: Number of subjects enrolled
    United States: 5
    Country: Number of subjects enrolled
    Switzerland: 2
    Worldwide total number of subjects
    129
    EEA total number of subjects
    117
    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)
    53
    From 65 to 84 years
    76
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients who completed a previous core study and met the inclusion/exclusion criteria entered the open-label treatment phase.

    Pre-assignment
    Screening details
    Patients who entered into this open-label treatment study within one week of completion of the last entered the study directly and the screening and baseline visit was performed on the same day. If more than one week after completion of the last visit of the core study; patients underwent a separate screening and baseline visit .

    Period 1
    Period 1 title
    Open-label Treatment Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    AFQ056 25 mg b.i.d.
    Arm description
    AFQ056 25 mg for oral administration
    Arm type
    Experimental

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The investigational drug, AFQ056, was provided as hard gelatin capsules. All patients took one capsule in the morning and in the evening.

    Arm title
    AFQ056 50 mg b.i.d.
    Arm description
    AFQ056 50 mg for oral administration
    Arm type
    Experimental

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The investigational drug, AFQ056, was provided as hard gelatin capsules. All patients took one capsule in the morning and in the evening.

    Arm title
    AFQ056 75 mg b.i.d.
    Arm description
    AFQ056 75 mg for oral administration
    Arm type
    Experimental

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The investigational drug, AFQ056, was provided as hard gelatin capsules. All patients took one capsule in the morning and in the evening.

    Arm title
    AFQ056 100 mg b.i.d.
    Arm description
    AFQ056 100 mg for oral administration
    Arm type
    Experimental

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The investigational drug, AFQ056, was provided as hard gelatin capsules. All patients took one capsule in the morning and in the evening.

    Number of subjects in period 1
    AFQ056 25 mg b.i.d. AFQ056 50 mg b.i.d. AFQ056 75 mg b.i.d. AFQ056 100 mg b.i.d.
    Started
    20
    20
    20
    69
    Completed
    0
    0
    0
    0
    Not completed
    20
    20
    20
    69
         Protocol deviation
    -
    1
    -
    -
         Physician decision
    1
    1
    -
    1
         'New Therapy For Study Indication '
    1
    -
    -
    -
         Lack of efficacy
    -
    -
    -
    7
         Adverse event, non-fatal
    5
    7
    2
    13
         Subject/Guardian Decision
    2
    1
    -
    1
         Study Terminated By Sponsor
    10
    10
    17
    47
         Lost to follow-up
    1
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AFQ056 25 mg b.i.d.
    Reporting group description
    AFQ056 25 mg for oral administration

    Reporting group title
    AFQ056 50 mg b.i.d.
    Reporting group description
    AFQ056 50 mg for oral administration

    Reporting group title
    AFQ056 75 mg b.i.d.
    Reporting group description
    AFQ056 75 mg for oral administration

    Reporting group title
    AFQ056 100 mg b.i.d.
    Reporting group description
    AFQ056 100 mg for oral administration

    Reporting group values
    AFQ056 25 mg b.i.d. AFQ056 50 mg b.i.d. AFQ056 75 mg b.i.d. AFQ056 100 mg b.i.d. Total
    Number of subjects
    20 20 20 69 129
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    0
        From 65-84 years
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65.9 ± 8.69 67.5 ± 7.93 62.9 ± 8.64 65.9 ± 8.79 -
    Gender categorical
    Units: Subjects
        Female
    7 13 6 29 55
        Male
    13 7 14 40 74

    End points

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    End points reporting groups
    Reporting group title
    AFQ056 25 mg b.i.d.
    Reporting group description
    AFQ056 25 mg for oral administration

    Reporting group title
    AFQ056 50 mg b.i.d.
    Reporting group description
    AFQ056 50 mg for oral administration

    Reporting group title
    AFQ056 75 mg b.i.d.
    Reporting group description
    AFQ056 75 mg for oral administration

    Reporting group title
    AFQ056 100 mg b.i.d.
    Reporting group description
    AFQ056 100 mg for oral administration

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS included all patients who received at least one dose of study medication during this open-label study.

    Subject analysis set title
    Safety Set (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The SS consisted of all patients who received at least one dose of open-label study drug during this open-label study and who had at least one post- baseline safety assessment.

    Primary: Percentage of patients with at least one treatment emergent AEs

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    End point title
    Percentage of patients with at least one treatment emergent AEs [1]
    End point description
    Treatment-emergent adverse event (TEAE) was defined as any AE newly occurred or worsened in severity after starting study drug during the open-label treatment phase.
    End point type
    Primary
    End point timeframe
    From Baseline for duration of study until early termination (04Nov2013)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analyses have been performed for this primary end point.
    End point values
    AFQ056 25 mg b.i.d. AFQ056 50 mg b.i.d. AFQ056 75 mg b.i.d. AFQ056 100 mg b.i.d.
    Number of subjects analysed
    20
    20
    20
    69
    Units: Percentage of participants
        number (not applicable)
    90
    95
    100
    72.5
    No statistical analyses for this end point

    Primary: Summary of severity of adverse events including serious adverse events

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    End point title
    Summary of severity of adverse events including serious adverse events [2]
    End point description
    The occurrence and severity of adverse events would be sought by non-directive questioning of the patient at each visit. Adverse events may also be detected when they are volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessment.
    End point type
    Primary
    End point timeframe
    From Baseline for duration of study until early termination (04Nov2013)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analyses have been performed for this primary end point.
    End point values
    AFQ056 25 mg b.i.d. AFQ056 50 mg b.i.d. AFQ056 75 mg b.i.d. AFQ056 100 mg b.i.d.
    Number of subjects analysed
    18 [3]
    19 [4]
    20 [5]
    50 [6]
    Units: percentage
    number (not applicable)
        Mild
    35
    15
    45
    21.7
        Moderate
    30
    65
    45
    30.4
        Severe
    25
    15
    10
    20.3
    Notes
    [3] - Patients with any AE
    [4] - Patients with any AE
    [5] - Patients with any AE
    [6] - Patients with any AE
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    AFQ056 25 MG
    Reporting group description
    AFQ056 25 MG

    Reporting group title
    AFQ056 50 MG
    Reporting group description
    AFQ056 50 MG

    Reporting group title
    AFQ056 75 MG
    Reporting group description
    AFQ056 75 MG

    Reporting group title
    AFQ056 100 MG
    Reporting group description
    AFQ056 100 MG

    Serious adverse events
    AFQ056 25 MG AFQ056 50 MG AFQ056 75 MG AFQ056 100 MG
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
    6 / 20 (30.00%)
    2 / 20 (10.00%)
    16 / 69 (23.19%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    CERVICAL VERTEBRAL FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FEMUR FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FRACTURED SACRUM
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HAND FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HUMERUS FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PELVIC FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RIB FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    2 / 69 (2.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SKULL FRACTURED BASE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TENDON RUPTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ULNA FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    FIBRIN D DIMER INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    DIAPHRAGMATIC RUPTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    2 / 69 (2.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    IRON DEFICIENCY ANAEMIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    AKINESIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DYSKINESIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    EPILEPSY
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FREEZING PHENOMENON
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ISCHAEMIC STROKE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    METABOLIC ENCEPHALOPATHY
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NYSTAGMUS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ON AND OFF PHENOMENON
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    2 / 69 (2.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PARKINSON'S DISEASE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    SUDDEN HEARING LOSS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    APATHY
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HALLUCINATION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MENTAL STATUS CHANGES
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INGUINAL HERNIA, OBSTRUCTIVE
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    CERVICAL SPINAL STENOSIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INTERVERTEBRAL DISC DEGENERATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SPINAL COLUMN STENOSIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SYNOVIAL CYST
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    HYPOVOLAEMIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    AFQ056 25 MG AFQ056 50 MG AFQ056 75 MG AFQ056 100 MG
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 20 (90.00%)
    18 / 20 (90.00%)
    20 / 20 (100.00%)
    46 / 69 (66.67%)
    Vascular disorders
    CIRCULATORY COLLAPSE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    HYPERTENSION
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    2 / 20 (10.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    3
    2
    1
    HYPOTENSION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    2
    0
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 69 (2.90%)
         occurrences all number
    3
    0
    0
    3
    RAYNAUD'S PHENOMENON
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    THROMBOPHLEBITIS SUPERFICIAL
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    1
    1
    0
    DEVICE DISLOCATION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    FATIGUE
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    2
    0
    1
    0
    GAIT DISTURBANCE
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    1
    0
    0
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    OEDEMA PERIPHERAL
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    PYREXIA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    ABNORMAL DREAMS
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    2 / 69 (2.90%)
         occurrences all number
    2
    2
    1
    2
    ANXIETY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    1
    1
    APATHY
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    1
    1
    0
    COMPULSIVE SHOPPING
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    CONFUSIONAL STATE
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 20 (15.00%)
    3 / 20 (15.00%)
    2 / 69 (2.90%)
         occurrences all number
    3
    4
    3
    3
    DELIRIUM
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    DEPRESSED MOOD
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    0
    0
    DEPRESSION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    3 / 69 (4.35%)
         occurrences all number
    0
    0
    2
    3
    HALLUCINATION, AUDITORY
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    HALLUCINATION, VISUAL
         subjects affected / exposed
    3 / 20 (15.00%)
    5 / 20 (25.00%)
    4 / 20 (20.00%)
    2 / 69 (2.90%)
         occurrences all number
    6
    6
    4
    2
    ILLUSION
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 20 (20.00%)
    3 / 20 (15.00%)
    1 / 69 (1.45%)
         occurrences all number
    1
    5
    3
    2
    INSOMNIA
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    4 / 69 (5.80%)
         occurrences all number
    1
    1
    2
    4
    LIBIDO INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    1
    1
    NIGHTMARE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    RAPID EYE MOVEMENTS SLEEP ABNORMAL
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    SLEEP DISORDER
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    1
    1
    1
    Injury, poisoning and procedural complications
    BONE CONTUSION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    EXCORIATION
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    2
    0
    0
    FALL
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 20 (20.00%)
    2 / 20 (10.00%)
    6 / 69 (8.70%)
         occurrences all number
    1
    8
    2
    9
    HAND FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    1
    0
    1
    HEAD INJURY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    PERIORBITAL HAEMATOMA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    1
    1
    THERMAL BURN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    WOUND
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    AMYLASE INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    BLOOD PRESSURE INCREASED
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    1
    0
    1
    1
    BLOOD TRIGLYCERIDES INCREASED
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences all number
    1
    0
    0
    1
    CARDIAC MURMUR
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    HAEMATOCRIT DECREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    HAEMOGLOBIN DECREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    RED BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    WEIGHT DECREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    2 / 69 (2.90%)
         occurrences all number
    0
    0
    1
    2
    Cardiac disorders
    CONDUCTION DISORDER
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    0
    0
    DIASTOLIC DYSFUNCTION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    PALPITATIONS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    DYSPHONIA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    DYSPNOEA
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    2
    1
    0
    PULMONARY ARTERIAL HYPERTENSION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    PULMONARY EMBOLISM
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    RESPIRATORY DISTRESS
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    AKINESIA
         subjects affected / exposed
    5 / 20 (25.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    3 / 69 (4.35%)
         occurrences all number
    6
    1
    2
    3
    BRADYKINESIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    3
    1
    COGNITIVE DISORDER
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    0
    0
    DISTURBANCE IN ATTENTION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    DIZZINESS
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    6 / 69 (8.70%)
         occurrences all number
    3
    2
    1
    11
    DYSKINESIA
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 20 (15.00%)
    2 / 20 (10.00%)
    13 / 69 (18.84%)
         occurrences all number
    0
    4
    3
    17
    FREEZING PHENOMENON
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    1
    0
    HYPOAESTHESIA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    HEADACHE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    3 / 69 (4.35%)
         occurrences all number
    0
    0
    1
    3
    HYPOKINESIA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    2
    0
    NERVE COMPRESSION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    0
    0
    ON AND OFF PHENOMENON
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 20 (15.00%)
    4 / 20 (20.00%)
    6 / 69 (8.70%)
         occurrences all number
    1
    3
    4
    7
    PARAESTHESIA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    2 / 69 (2.90%)
         occurrences all number
    0
    1
    0
    2
    PRESYNCOPE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    POOR QUALITY SLEEP
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    PSYCHOMOTOR HYPERACTIVITY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    RESTING TREMOR
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    0
    0
    SCIATICA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    SOMNOLENCE
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 20 (15.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    1
    3
    2
    1
    TREMOR
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    1
    0
    2
    VIBRATORY SENSE INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye disorders
    VISION BLURRED
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    1 / 69 (1.45%)
         occurrences all number
    1
    1
    2
    2
    VISUAL IMPAIRMENT
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    1
    1
    Ear and labyrinth disorders
    TINNITUS
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    1
    0
    0
    VERTIGO
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences all number
    1
    0
    0
    2
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 69 (2.90%)
         occurrences all number
    1
    0
    0
    2
    CONSTIPATION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    5 / 69 (7.25%)
         occurrences all number
    0
    1
    1
    5
    DENTAL CARIES
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    DIARRHOEA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    DYSPHAGIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    1
    1
    GASTRITIS
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    0
    0
    NAUSEA
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    3 / 69 (4.35%)
         occurrences all number
    0
    2
    0
    3
    VOMITING
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    2 / 69 (2.90%)
         occurrences all number
    0
    1
    0
    2
    Renal and urinary disorders
    INCONTINENCE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    URGE INCONTINENCE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    ERYTHEMA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NIGHT SWEATS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    1
    1
    RASH
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    2 / 69 (2.90%)
         occurrences all number
    1
    3
    0
    2
    BACK PAIN
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    2 / 69 (2.90%)
         occurrences all number
    2
    1
    0
    3
    JOINT SWELLING
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    LUMBAR SPINAL STENOSIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    MOBILITY DECREASED
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 69 (2.90%)
         occurrences all number
    1
    0
    0
    2
    MUSCLE RIGIDITY
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    MUSCLE SPASMS
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    1
    0
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    1
    0
    0
    OSTEOARTHRITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    1
    0
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    3 / 69 (4.35%)
         occurrences all number
    0
    1
    0
    3
    POLYARTHRITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    0
    0
    GOUT
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    HYPERCHOLESTEROLAEMIA
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    1
    0
    HYPOCALCAEMIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    HYPONATRAEMIA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    INCREASED APPETITE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    VITAMIN B12 DEFICIENCY
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 69 (1.45%)
         occurrences all number
    1
    0
    0
    1
    Infections and infestations
    EAR INFECTION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    9 / 69 (13.04%)
         occurrences all number
    2
    1
    2
    9
    PURULENT DISCHARGE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    1
    0
    0
    RHINITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    1
    1
    TOOTH ABSCESS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    1
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    4 / 69 (5.80%)
         occurrences all number
    2
    0
    1
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jun 2012
    The protocol was amended to allow concomitant treatment with amantadine and to collect long-term safety and safety data on concomitant amantadine and AFQ056 in this patient population. Amantadine was frequently used to treat LIDs and permitting concomitant treatment with AFQ056 may provide additional treatment options for these patients. AEs associated with amantadine are similar to AFQ056 (e.g. dizziness, hallucinations, fatigue), and concomitant administration with AFQ056 may increase the likelihood of these AEs. However, these events were expected to be transient and reversible. In addition, the amended protocol, in line with the FDA Guidance on the prospective suicidality assessment in clinical trials, required the C-SSRS to be assessed at every postbaseline visit, including unscheduled visits.

    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.
    The study was terminated based on the results of studies CAFQ056A2222 and CAFQ056A2223 (due to lack of efficacy) and the sponsor’s decision to terminate the program
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