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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, study of oral treatment of piromelatine in patients with ocular hypertension (OHT) or primary open angle glaucoma (POAG).

    Summary
    EudraCT number
    		 2016-002281-31
    Trial protocol
    		 ES  
    Global end of trial date
    26 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2021
    First version publication date
    22 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Piromelatine-IOP1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Neurim Pharmaceuticals (1991) Ltd.
    Sponsor organisation address
    27 HaBarzel St., Tel Aviv, Israel, 69710
    Public contact
    Clinical Trials Information, QPS Austria GmbH, 0043 31625811, Ricarda.Cerroni@qps.com
    Scientific contact
    Clinical Trials Information, QPS Austria GmbH, 0043 31625811, Ricarda.Cerroni@qps.com
    Sponsor organisation name
    Neurim Pharmaceuticals (1991)
    Sponsor organisation address
    HaBarzel 27, Tel Aviv, Israel,
    Public contact
    Tali Nir, Neurim Pahrmaceuticals, talin@neurim.com
    Scientific contact
    Tali Nir, Neurim Pahrmaceuticals, talin@neurim.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
    01 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of 30 days piromelatine treatment vs placebo in ocular hypertension (OHT) or primary open angle glaucoma (POAG) patients.
    Protection of trial subjects
    This clinical trial was conducted in compliance with the current revision of the Declaration of Helsinki, ICH guideline for Good Clinical Practice (GCP) and current regulatory regulations (WMO). The principles of informed consent were implemented according to the 2013 version of the Declaration of Helsinki, the ICH Guideline for Good Clinical Practice (GCP) and regulatory requirements (WMO).
    Background therapy
    		 N.A.
    Evidence for comparator
    		 A placebo group was required in order to differentiate any investigational drug effect from any improvement that could occur solely due to the close care and medical oversight given to the patients under trial conditions. The matching placebo tablets for piromelatine contained only the excipients and were indistinguishable from the piromelatine tablets.
    Actual start date of recruitment
    19 Jan 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
    Spain: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    21
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients had to be clinically diagnosed with either POAG or OHT in both eyes and hat to fulfill the following main criteria: Aged between 40 and 80 years, of either sex. Morning IOP: 22-30 mmHg (incl.) not pregnant

    Pre-assignment
    Screening details
    		 Patients had to be clinically diagnosed with either POAG or OHT in both eyes and had to fulfill the following main criteria: Aged between 40 and 80 years, of either sex. Morning IOP: 22-30 mmHg (incl.) No other glaucoma type, advanced visual field loss, ocular trauma, infection, pathology, progressive retinal disease not pregnant, good health

    Pre-assignment period milestones
    Number of subjects started
    		 40
    Number of subjects completed
    		 40

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Piromelatine 20mg/40mg
    Arm description
    		 During dosing period each patient received an oral daily dose of piromelatine 20 mg or matching placebo and after 2 weeks non responders (Patients with no improvement in their IOP measurement, defined as decrease of <15% of baseline or worsening within the inclusion criteria range) received 40 mg (2 tablets of 20 mg) or matching placebo (2 tablets).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Piromelatine
    Investigational medicinal product code
    Neu-P11
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    20 mg oral administration

    Arm title
    		 placebo
    Arm description
    		 Placebo - tablets similar in appearance to active
    Arm type
    		 Placebo

    Investigational medicinal product name
    Piromelatine
    Investigational medicinal product code
    Neu-P11
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    20 mg oral administration

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    2 tablets, oral administration

    Arm title
    		 Piromelatine 20 mg
    Arm description
    		 During dosing period each patient received an oral daily dose of piromelatine 20 mg or matching placebo and after 2 weeks non responders (Patients with no improvement in their IOP measurement, defined as decrease of <15% of baseline or worsening within the inclusion criteria range) received 40 mg (2 tablets of 20 mg) or matching placebo (2 tablets).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Piromelatine
    Investigational medicinal product code
    Neu-P11
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    20 mg oral administration

    Number of subjects in period 1
    		Piromelatine 20mg/40mg placebo Piromelatine 20 mg
    Started
    16
    21
    3
    Completed
    16
    21
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Piromelatine 20mg/40mg
    Reporting group description
    		 During dosing period each patient received an oral daily dose of piromelatine 20 mg or matching placebo and after 2 weeks non responders (Patients with no improvement in their IOP measurement, defined as decrease of <15% of baseline or worsening within the inclusion criteria range) received 40 mg (2 tablets of 20 mg) or matching placebo (2 tablets).

    Reporting group title
    placebo
    Reporting group description
    		 Placebo - tablets similar in appearance to active

    Reporting group title
    Piromelatine 20 mg
    Reporting group description
    		 During dosing period each patient received an oral daily dose of piromelatine 20 mg or matching placebo and after 2 weeks non responders (Patients with no improvement in their IOP measurement, defined as decrease of <15% of baseline or worsening within the inclusion criteria range) received 40 mg (2 tablets of 20 mg) or matching placebo (2 tablets).

    Reporting group values
    		 Piromelatine 20mg/40mg placebo Piromelatine 20 mg Total
    Number of subjects
    		 16 21 3 40
    Age categorical
    Units: Subjects
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 7 12 2 21
        From 65-84 years
    		 9 9 1 19
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 12 1 22
        Male
    		 7 9 2 18
    Subject analysis sets

    Subject analysis set title
    ASR Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    AST: All Subjects Randomized Set - all randomized patients

    Subject analysis set title
    AST Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    AST: All Subjects Treated Set - all randomised patients who took at least one dose of IMP during the study period.

    Subject analysis sets values
    		 ASR Set AST Set
    Number of subjects
    38
    40
    Age categorical
    Units: Subjects
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    21
    21
        From 65-84 years
    17
    19
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    20
    22
        Male
    18
    18

    End points

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    End points reporting groups
    Reporting group title
    Piromelatine 20mg/40mg
    Reporting group description
    		 During dosing period each patient received an oral daily dose of piromelatine 20 mg or matching placebo and after 2 weeks non responders (Patients with no improvement in their IOP measurement, defined as decrease of <15% of baseline or worsening within the inclusion criteria range) received 40 mg (2 tablets of 20 mg) or matching placebo (2 tablets).

    Reporting group title
    placebo
    Reporting group description
    		 Placebo - tablets similar in appearance to active

    Reporting group title
    Piromelatine 20 mg
    Reporting group description
    		 During dosing period each patient received an oral daily dose of piromelatine 20 mg or matching placebo and after 2 weeks non responders (Patients with no improvement in their IOP measurement, defined as decrease of <15% of baseline or worsening within the inclusion criteria range) received 40 mg (2 tablets of 20 mg) or matching placebo (2 tablets).

    Subject analysis set title
    ASR Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    AST: All Subjects Randomized Set - all randomized patients

    Subject analysis set title
    AST Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    AST: All Subjects Treated Set - all randomised patients who took at least one dose of IMP during the study period.

    Primary: Primary endpoint: The safety parameters were summarized using descriptive statistics: n, mean, median, standard deviation (SD), standard error of the mean (SEM), minimum, maximum, number of out-of-range values if applicable.

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    End point title
    		 Primary endpoint: The safety parameters were summarized using descriptive statistics: n, mean, median, standard deviation (SD), standard error of the mean (SEM), minimum, maximum, number of out-of-range values if applicable. [1]
    End point description
    ANCOVA for Diastolic Blood Pressure - Comparison of Placebo with Piromelatine 20mg and Placebo with Piromelatine 20mg/40mg ANCOVA for Systolic Blood Pressure - Comparison of Placebo with Piromelatine 20mg and Placebo with Piromelatine 20mg/40mg ANCOVA for Heart Rate - Comparison of Placebo with Piromelatine 20mg and Placebo with Piromelatine 20mg/40mg
    End point type
    Primary
    End point timeframe
    Assessment of this endpoints were conducted at following visits: Visit 2 (Day 0), Visit 3 (Day 15 +/-2), Visit 3 (Day 30 +/-2)
    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: ANCOVA was performed for comparison of Placebo with Piromelatine 20mg and Placebo with Piromelatine 20mg/40mg. No data were evaluated for the Placebo treatement arm.
    End point values
    		 Piromelatine 20mg/40mg Piromelatine 20 mg
    Number of subjects analysed
    16
    3
    Units: mmHg
    arithmetic mean (confidence interval 95%)
        Diastolic Blood Pressure
    -4.4298 (-12.7446 to 3.8850)
    6.1815 (-8.4513 to 20.8144)
        Systolic Blood Pressure
    -4.5511 (-16.4099 to 7.3076)
    26.3778 (5.7670 to 46.9886)
        Heart Rate
    -5.3662 (-12.8798 to 2.1474)
    -5.9334 (-20.4112 to 8.5444)
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    Piromelatine 20mg/40mg v Piromelatine 20 mg
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: IOP – Intraocular pressure at supine and sitting position at night time and during the day

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    End point title
    		 IOP – Intraocular pressure at supine and sitting position at night time and during the day
    End point description
    The efficacy analysis for the secondary and exploratory endpoints were carried out using an analysis of covariance (ANCOVA) model with treatment as the main effect and baseline score and study site as covariates. For IOP, the statistical analysis was done for the data obtained from the eye with the higher baseline IOP. If baseline IOP was the same in the two eyes (±2 mm Hg) the right eye IOP was used.
    End point type
    Secondary
    End point timeframe
    Assssments of this endpoint were conductd at the following visits: Visit 2 (Day 0), Visit 3 (Day 15 +/-2), Visit 4 (Day 30 +/-2)
    End point values
    		 ASR Set AST Set
    Number of subjects analysed
    38
    40
    Units: mmHg
    median (confidence interval 95%)
        Daytime sitting IOP (Piromelatine vs Placebo)
    -0.4562 (-1.7040 to 0.7916)
    -0.4394 (-1.6201 to 0.7414)
        Daytime supine IOP (Piromelatine vs Placebo)
    0.1638 (-1.0491 to 1.3766)
    0.1092 (-1.0461 to 1.2645)
        Nighttime supine IOP (Piromelatine vs Placebo)
    -0.3446 (-1.6800 to 0.9908)
    -0.1670 (-1.4500 to 1.1160)
        Overall IOP (Piromelatine vs Placebo)
    -0.2588 (-1.3975 to 0.8799)
    -0.2383 (-1.3156 to 0.8390)
        Overall supine IOP (Piromelatine vs Placebo
    -0.02481 (-1.1326 to 1.0830)
    0.02946 (-1.0200 to 1.0789)
    No statistical analyses for this end point

    Secondary: PF - The difference of IOP in the supine and sitting position at each time point

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    End point title
    		 PF - The difference of IOP in the supine and sitting position at each time point
    End point description
    End point type
    Secondary
    End point timeframe
    Assessment of this endpoint was calulated at following visits: Visit 2 (Day 0), Visit 3 (Day 15 +/-2), Day 4 (Day 30 +/-2)
    End point values
    		 ASR Set AST Set
    Number of subjects analysed
    38
    40
    Units: mmHg
    median (confidence interval 95%)
        IOP Postural fluctuation (1-1.5 h)
    -0.4466 (-1.7351 to 0.8419)
    -0.4287 (-1.6556 to 0.7982)
        IOP Postural fluctuation (4-4.5h)
    1.6944 (0.2955 to 3.0933)
    1.3723 (-0.02757 to 2.7722)
        IOP Postural fluctuation (5-5.5h)
    -0.00420 (-0.9819 to 0.9735)
    0.02792 (-0.8944 to 0.9503)
        IOP Postural fluctuation (6-6.5h)
    0.1578 (-0.7789 to 1.0945)
    0.2100 (-0.6729 to 1.0929)
    No statistical analyses for this end point

    Secondary: DV – The difference between maximum and minimum IOP during the 24 h period DV for sitting and supine postures

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    End point title
    		 DV – The difference between maximum and minimum IOP during the 24 h period DV for sitting and supine postures
    End point description
    End point type
    Secondary
    End point timeframe
    Assessment of this endpoints were conducted at following visits: Visit 2 (Day 0), Visit 3 (Day 15 +/-2), Visit 4 (Day 30 +/-2)
    End point values
    		 ASR Set AST Set
    Number of subjects analysed
    38
    40
    Units: mmHg
    median (confidence interval 95%)
        IOP Diural Variations sitting
    -0.2950 (-1.6354 to 1.0454)
    -0.3694 (-1.6380 to 0.8992)
        IOP Diural Variations supine
    0.3383 (-0.8530 to 1.5296)
    0.2379 (-0.8964 to 1.3723)
    No statistical analyses for this end point

    Other pre-specified: Sleep questionnaire items - how long till fall asleep

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    End point title
    		 Sleep questionnaire items - how long till fall asleep
    End point description
    Change from Baseline
    End point type
    Other pre-specified
    End point timeframe
    Assessment of this endpoints were conducted at following visits: Visit 2 (Day 0), Visit 4 (Day 30 +/+2)
    End point values
    		 Piromelatine 20mg/40mg placebo Piromelatine 20 mg
    Number of subjects analysed
    15
    20
    3
    Units: minutes
    arithmetic mean (standard deviation)
        ASR set
    -10.3 ( 44.8 )
    -0.8 ( 27.0 )
    11.7 ( 48.6 )
        AST set
    -9.7 ( 43.3 )
    -0.8 ( 26.3 )
    11.7 ( 48.6 )
    No statistical analyses for this end point

    Other pre-specified: Sleep questionnaire items - Feeling in the morning

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    End point title
    		 Sleep questionnaire items - Feeling in the morning
    End point description
    Change from Baseline
    End point type
    Other pre-specified
    End point timeframe
    Assessment of this endpoints were conducted at following visits: Visit 2 (Day 0), Visit 4 (Day 30 +/+2)
    End point values
    		 Piromelatine 20mg/40mg placebo Piromelatine 20 mg
    Number of subjects analysed
    15
    20
    3
    Units: N.A.
    arithmetic mean (standard deviation)
        ASR set
    -0.3 ( 1.2 )
    -0.5 ( 0.8 )
    -0.7 ( 0.6 )
        AST set
    -0.7 ( 0.6 )
    -0.3 ( 1.2 )
    -0.4 ( 0.8 )
    No statistical analyses for this end point

    Other pre-specified: Sleep questionnaire items - actual sleep

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    End point title
    		 Sleep questionnaire items - actual sleep
    End point description
    Change from Baseline
    End point type
    Other pre-specified
    End point timeframe
    Assessment of this endpoints were conducted at following visits: Visit 2 (Day 0), Visit 4 (Day 30 +/-2)
    End point values
    		 Piromelatine 20mg/40mg placebo Piromelatine 20 mg
    Number of subjects analysed
    15
    20
    3
    Units: hours
    arithmetic mean (standard deviation)
        ASR set
    10.2 ( 15.5 )
    4.9 ( 21.0 )
    -7.7 ( 15.1 )
        AST set
    9.6 ( 15.2 )
    4.7 ( 20.5 )
    -7.7 ( 15.1 )
    No statistical analyses for this end point

    Other pre-specified: Sleep questionnaire items - sleep quality overall

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    End point title
    		 Sleep questionnaire items - sleep quality overall
    End point description
    Change from Baseline
    End point type
    Other pre-specified
    End point timeframe
    Assessment of this endpoints were conducted at following visits: Visit 2 (Day 0), Visit 4 (Day 30 +/-2)
    End point values
    		 Piromelatine 20mg/40mg placebo Piromelatine 20 mg
    Number of subjects analysed
    15
    20
    3
    Units: N.A.
    arithmetic mean (standard deviation)
        ASR set
    -0.1 ( 0.9 )
    -0.5 ( 0.9 )
    0.0 ( 0.0 )
        AST set
    -0.1 ( 0.9 )
    -0.4 ( 0.9 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Ambulatory blood pressure monitoring (ABPM)

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    End point title
    		 Ambulatory blood pressure monitoring (ABPM)
    End point description
    Change from Baseline
    End point type
    Other pre-specified
    End point timeframe
    The ABPM was measured at Visit 2 (baseline) and Visit 4. The ABPM was programmed to record blood pressure every 60 minutes during day time (8:00-1:00) and every 120 minutes at IOP measureme.
    End point values
    		 Piromelatine 20mg/40mg placebo Piromelatine 20 mg
    Number of subjects analysed
    9
    16
    3
    Units: mmHg
    arithmetic mean (standard deviation)
        Diastolic blood pressure
    -1.3 ( 9.4 )
    4.1 ( 12.5 )
    8.3 ( 14.2 )
        Systolic blood pressure
    -6.3 ( 9.9 )
    1.1 ( 18.8 )
    21.0 ( 22.3 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE collection started with administration of the IMP and continued until the follow-up assessment. At the follow-up Visit, information on new AEs or SAEs and stop dates for AEs recorded and ongoing during the dosig period were recorded.
    Adverse event reporting additional description
    AEs which occurred after the subject had signed the Informed Consent Form but before the first administration of IMP (pre-treatment adverse events) were collected in the same manner as AEs which occured after the first administration of IMP.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 All subjects randomized to receive placebo.

    Reporting group title
    Piromelatine 20mg
    Reporting group description
    		 All subjects randomized to receive Piromelatine 20 mg Tablets.

    Reporting group title
    Piromelatine 20mg/40mg
    Reporting group description
    		 During dosing period each patient received an oral daily dose of piromelatine 20 mg or matching placebo and after 2 weeks non responders (Patients with no improvement in their IOP measurement, defined as decrease of <15% of baseline or worsening within the inclusion criteria range) received 40 mg (2 tablets of 20 mg) or matching placebo (2 tablets).

    Serious adverse events
    		 Placebo Piromelatine 20mg Piromelatine 20mg/40mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Piromelatine 20mg Piromelatine 20mg/40mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 21 (28.57%)
    1 / 3 (33.33%)
    4 / 16 (25.00%)
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Labile blood pressure
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    2
    0
    2
    Dizziness
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Migraine
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jan 2017
    This amendment is issued to introduce changes in the conduct or management of the trial including updating the XML file with changes realted to the tasks and functions transfered by the sponsor to other organizations, as well as to the decision of the sponsor to reject the participation of the center planned in the Czech Republic to ensure timely completion of the clinical trial; To present an updated version of the IMPD; And to submit a new version of the Informed Consent Form/Patient Information Document (CI/IP) adapted with the new information.
    28 Mar 2017
    This amendment was issued to introduce changes in the conduct or management of the trial, including updating the XML file with changes relatet to the organization and person of contact of the legal representative of the Sponsor. In addition, it is agreed to notify the re-labeling of the medication in accordance with the specifications of the updated IMPD (version 8.0, dated 17 January 2017).

    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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