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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Single-Dose Pharmacokinetics of MK-0462 in Migraineurs Aged 6 to 17 Years

    Summary
    EudraCT number
    		 2011-002348-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Sep 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 May 2016
    First version publication date
    05 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    0462-083
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00604812
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000084-PIP02-10
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Sep 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Sep 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric participants with migraines. After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female participants. Therefore, the study was amended to add an additional panel of participants (Panel C) to ensure gender balance specifically in this age group.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Dec 2007
    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
    United States: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    0
    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)
    13
    Adolescents (12-17 years)
    18
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 31 subjects were enrolled in the study.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Panel A Rizatriptan
    Arm description
    		 Participants allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Participants weighing 20-39 kg were allocated to Panel A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    rizatriptan benzoate (5 mg)
    Investigational medicinal product code
    Other name
    MAXALT®, MK-0462
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single dose of rizatriptan 5 mg administered on Day 1.

    Arm title
    		 Panel A Placebo
    Arm description
    		 Participants allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg ODT placebo on Day 1. Participants weighing 20-39 kg were allocated to Panel A.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Rizatriptan 5 mg Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single dose of rizatriptan 5 mg placebo administered on Day 1.

    Arm title
    		 Panel B Rizatriptan
    Arm description
    		 Participants allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg ODT on Day 1. Participants weighing 40 kg and above were allocated to Panel B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    rizatriptan benzoate (10 mg)
    Investigational medicinal product code
    Other name
    MAXALT®, MK-0462
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single dose of rizatriptan 10 mg administered on Day 1.

    Arm title
    		 Panel B Placebo
    Arm description
    		 Participants allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg ODT placebo on Day 1. Participants weighing 40 kg and above were allocated to Panel B.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Rizatriptan 10 mg Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single dose of rizatriptan 10 mg placebo administered on Day 1.

    Arm title
    		 Panel C Rizatriptan
    Arm description
    		 Participants allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Participants in Panel C weighing 20-39 kg received a 5 mg dose and participants weighing 40 kg and above received a 10 mg dose. Panel C was added to the study by amendment to increase the number of male participants in the 12-17 year old age group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    rizatriptan benzoate (5 mg)
    Investigational medicinal product code
    Other name
    MAXALT®, MK-0462
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single dose of rizatriptan 5 mg administered on Day 1.

    Investigational medicinal product name
    rizatriptan benzoate (10 mg)
    Investigational medicinal product code
    Other name
    MAXALT®, MK-0462
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single dose of rizatriptan 10 mg administered on Day 1.

    Arm title
    		 Panel C Placebo
    Arm description
    		 Participants allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Participants in Panel C weighing 20-39 kg received a 5 mg placebo dose and participants weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male participants in the 12-17 year old age group.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Rizatriptan 5 mg Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single dose of rizatriptan 5 mg placebo administered on Day 1.

    Investigational medicinal product name
    Rizatriptan 10 mg Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single dose of rizatriptan 10 mg placebo administered on Day 1.

    Number of subjects in period 1
    		Panel A Rizatriptan Panel A Placebo Panel B Rizatriptan Panel B Placebo Panel C Rizatriptan Panel C Placebo
    Started
    9
    3
    10
    3
    5
    1
    Completed
    9
    3
    10
    3
    5
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Panel A Rizatriptan
    Reporting group description
    		 Participants allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Participants weighing 20-39 kg were allocated to Panel A.

    Reporting group title
    Panel A Placebo
    Reporting group description
    		 Participants allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg ODT placebo on Day 1. Participants weighing 20-39 kg were allocated to Panel A.

    Reporting group title
    Panel B Rizatriptan
    Reporting group description
    		 Participants allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg ODT on Day 1. Participants weighing 40 kg and above were allocated to Panel B.

    Reporting group title
    Panel B Placebo
    Reporting group description
    		 Participants allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg ODT placebo on Day 1. Participants weighing 40 kg and above were allocated to Panel B.

    Reporting group title
    Panel C Rizatriptan
    Reporting group description
    		 Participants allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Participants in Panel C weighing 20-39 kg received a 5 mg dose and participants weighing 40 kg and above received a 10 mg dose. Panel C was added to the study by amendment to increase the number of male participants in the 12-17 year old age group.

    Reporting group title
    Panel C Placebo
    Reporting group description
    		 Participants allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Participants in Panel C weighing 20-39 kg received a 5 mg placebo dose and participants weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male participants in the 12-17 year old age group.

    Reporting group values
    		 Panel A Rizatriptan Panel A Placebo Panel B Rizatriptan Panel B Placebo Panel C Rizatriptan Panel C Placebo Total
    Number of subjects
    		 9 3 10 3 5 1 31
    Age categorical
    Units: Subjects
        Ages 6 to <12
    		 8 3 2 0 0 0 13
        Ages 12 to 17
    		 1 0 8 3 5 1 18
    Gender categorical
    Units: Subjects
        Female
    		 3 2 5 3 0 0 13
        Male
    		 6 1 5 0 5 1 18
    Weight
    Units: Subjects
        20-39 kg
    		 9 3 0 0 1 0 13
        ≥40 kg
    		 0 0 10 3 4 1 18
    Subject analysis sets

    Subject analysis set title
    Panel A
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes the participants from the 5 mg rizatriptan group (n=9) and the matching placebo group (n=3).

    Subject analysis set title
    Panel B
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes the participants from the 10 mg rizatriptan group (n=10) and the matching placebo group (n=3).

    Subject analysis set title
    Panel C
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1)

    Subject analysis set title
    Rizatriptan 5 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Combined participants from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg ODT on Day 1.

    Subject analysis set title
    Rizatriptan 10 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Combined participants from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg ODT on Day 1.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Combined Placebo groups from panels A, B, and C.

    Subject analysis sets values
    		 Panel A Panel B Panel C Rizatriptan 5 mg Rizatriptan 10 mg Placebo
    Number of subjects
    12
    13
    6
    10
    14
    7
    Age categorical
    Units: Subjects
        Ages 6 to <12
    11
    2
    0
    8
    2
    3
        Ages 12 to 17
    1
    11
    6
    2
    12
    4
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    5
    8
    0
    3
    5
    5
        Male
    7
    5
    6
    7
    9
    2
    Weight
    Units: Subjects
        20-39 kg
    12
    0
    1
    10
    0
    3
        ≥40 kg
    0
    13
    5
    0
    14
    4

    End points

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    End points reporting groups
    Reporting group title
    Panel A Rizatriptan
    Reporting group description
    		 Participants allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Participants weighing 20-39 kg were allocated to Panel A.

    Reporting group title
    Panel A Placebo
    Reporting group description
    		 Participants allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg ODT placebo on Day 1. Participants weighing 20-39 kg were allocated to Panel A.

    Reporting group title
    Panel B Rizatriptan
    Reporting group description
    		 Participants allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg ODT on Day 1. Participants weighing 40 kg and above were allocated to Panel B.

    Reporting group title
    Panel B Placebo
    Reporting group description
    		 Participants allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg ODT placebo on Day 1. Participants weighing 40 kg and above were allocated to Panel B.

    Reporting group title
    Panel C Rizatriptan
    Reporting group description
    		 Participants allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Participants in Panel C weighing 20-39 kg received a 5 mg dose and participants weighing 40 kg and above received a 10 mg dose. Panel C was added to the study by amendment to increase the number of male participants in the 12-17 year old age group.

    Reporting group title
    Panel C Placebo
    Reporting group description
    		 Participants allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Participants in Panel C weighing 20-39 kg received a 5 mg placebo dose and participants weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male participants in the 12-17 year old age group.

    Subject analysis set title
    Panel A
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes the participants from the 5 mg rizatriptan group (n=9) and the matching placebo group (n=3).

    Subject analysis set title
    Panel B
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes the participants from the 10 mg rizatriptan group (n=10) and the matching placebo group (n=3).

    Subject analysis set title
    Panel C
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1)

    Subject analysis set title
    Rizatriptan 5 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Combined participants from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg ODT on Day 1.

    Subject analysis set title
    Rizatriptan 10 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Combined participants from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg ODT on Day 1.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Combined Placebo groups from panels A, B, and C.

    Primary: Number of Participants with Serious and Non-Serious Adverse Events During Study

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    End point title
    		 Number of Participants with Serious and Non-Serious Adverse Events During Study [1]
    End point description
    All adverse events spontaneously reported by participant and/or observed by investigator. Analysis was performed on data obtained from the All Participants as Treated population, which is all participants who received at least one dose of the investigational drug.
    End point type
    Primary
    End point timeframe
    24 Hours
    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 statistical comparison of the presented study groups was performed for this measure.
    End point values
    		 Rizatriptan 5 mg Rizatriptan 10 mg Placebo
    Number of subjects analysed
    10
    14
    7
    Units: participants
        Serious Adverse Events
    0
    0
    0
        Non-Serious Adverse Events
    3
    7
    3
        No Adverse Events Reported
    7
    7
    4
    No statistical analyses for this end point

    Primary: Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Area Under the Curve (AUC(0-∞))

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    End point title
    		 Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Area Under the Curve (AUC(0-∞)) [2] [3]
    End point description
    Preliminary pharmacokinetics data; AUC(0-∞); i.e., area under the concentration-time plot. Analysis was performed on data obtained from the Per Protocol population, which is the subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.
    End point type
    Primary
    End point timeframe
    24 Hours
    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 statistical comparison of the presented study groups was performed for this measure.
    [3] - 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: Summary rizatriptan pharmacokinetic data is not provided for study arms that received only placebo (i.e, did not receive rizatriptan).
    End point values
    		 Panel A Rizatriptan Panel B Rizatriptan Panel C Rizatriptan
    Number of subjects analysed
    9
    10
    5
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    59.4 ± 11.5
    84 ± 19.8
    67.93 ± 25.17
    No statistical analyses for this end point

    Primary: Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Maximum Concentration (Cmax)

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    End point title
    		 Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Maximum Concentration (Cmax) [4] [5]
    End point description
    Preliminary pharmacokinetics data; Cmax; i.e, highest concentration of drug achieved. Analysis was performed on data obtained from the Per Protocol population, which is the subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violation
    End point type
    Primary
    End point timeframe
    24 Hours
    Notes
    [4] - 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 statistical comparison of the presented study groups was performed for this measure.
    [5] - 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: Summary rizatriptan pharmacokinetic data is not provided for study arms that received only placebo (i.e, did not receive rizatriptan).
    End point values
    		 Panel A Rizatriptan Panel B Rizatriptan Panel C Rizatriptan
    Number of subjects analysed
    9
    10
    5
    Units: ng/mL
        arithmetic mean (standard deviation)
    24.6 ± 7.2
    25 ± 8.1
    18.4 ± 5.5
    No statistical analyses for this end point

    Secondary: Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Time to Maximum Concentration (Tmax)

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    End point title
    		 Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Time to Maximum Concentration (Tmax) [6]
    End point description
    Preliminary pharmacokinetics data; Tmax; i.e., amount of time required to reach maximum concentration. Analysis was performed on data obtained from the Per Protocol population, which is the subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violation.
    End point type
    Secondary
    End point timeframe
    24 Hours
    Notes
    [6] - 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: Summary rizatriptan pharmacokinetic data is not provided for study arms that received only placebo (i.e, did not receive rizatriptan).
    End point values
    		 Panel A Rizatriptan Panel B Rizatriptan Panel C Rizatriptan
    Number of subjects analysed
    9
    10
    5
    Units: hours
        median (full range (min-max))
    1 (0.3 to 2)
    1.5 (0.3 to 3)
    1.3 (0.7 to 1.7)
    No statistical analyses for this end point

    Secondary: Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Apparent half-life (Apparent t½)

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    End point title
    		 Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Apparent half-life (Apparent t½) [7]
    End point description
    Preliminary pharmacokinetics data; Apparent t½. Analysis was performed on data obtained from the Per Protocol population, which is the subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violation.
    End point type
    Secondary
    End point timeframe
    24 Hours
    Notes
    [7] - 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: Summary rizatriptan pharmacokinetic data is not provided for study arms that received only placebo (i.e, did not receive rizatriptan).
    End point values
    		 Panel A Rizatriptan Panel B Rizatriptan Panel C Rizatriptan
    Number of subjects analysed
    9 [8]
    10 [9]
    5 [10]
    Units: hours
        arithmetic mean (standard deviation)
    1.3 ± 0.1
    1.6 ± 0.2
    1.6 ± 0.4
    Notes
    [8] - Summary statistics presented are the harmonic mean and pseudo-standard deviation
    [9] - Summary statistics presented are the harmonic mean and pseudo-standard deviation
    [10] - Summary statistics presented are the harmonic mean and pseudo-standard deviation
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 Hours
    Adverse event reporting additional description
    Analysis was performed on data obtained from the All Participants as Treated population, which is all participants who received at least one dose of the investigational drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Rizatriptan 5 mg
    Reporting group description
    		 Combined participants from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg ODT on Day 1.

    Reporting group title
    Rizatriptan 10 mg
    Reporting group description
    		 Combined participants from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg ODT on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Combined Placebo groups from panels A, B, and C.

    Serious adverse events
    		 Rizatriptan 5 mg Rizatriptan 10 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rizatriptan 5 mg Rizatriptan 10 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    7 / 14 (50.00%)
    3 / 7 (42.86%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    Scratch
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    2
    0
    Hypersomnia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Injection site pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    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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