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    Clinical Trial Results:
    An Open-Label Single-Dose Study to Evaluate the Pediatric Palatability of Maxalt Oral Disintegrating Tablets

    Summary
    EudraCT number
    		 2011-002349-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Feb 2011

    Results information
    Results version number
    		 v1
    This version publication date
    08 Mar 2016
    First version publication date
    11 Mar 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-0462-107
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    28 Feb 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the palatability of rizatriptan benzoate orally disintegrating tablets (Maxalt-MLT™ ODT) in healthy young male and female subjects, 6 to less than 12 years of age, with a history of migraines , who were not experiencing a migraine on the day of the assessment.
    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
    02 Feb 2011
    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: 12
    Worldwide total number of subjects
    12
    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)
    12
    Adolescents (12-17 years)
    0
    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
    		 Screening occurred within 3 weeks prior to randomisation. Participants were 6 to less than 12 years of age with a history of migraines for at least 6 months but free of migraine on the day of study drug administration, weighed at least 20 kg, and were in good health at the time of screening.

    Period 1
    Period 1 title
    Single Dose Rizatriptan ODT (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Rizatriptan benzoate ODT
    Arm description
    		 Subjects were administered a single dose of either 5-mg or 10-mg rizatriptan benzoate ODT in open label fashion with the specific dose determined by the subject’s weight at predose on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rizatriptan Benzoate ODT
    Investigational medicinal product code
    Other name
    Maxalt-MLT™ ODT
    Pharmaceutical forms
    Oral lyophilisate
    Routes of administration
    Oral use
    Dosage and administration details
    Participants weighing 20-39.9 kg received a 5 mg dose of rizatriptan benzoate (Maxalt-MLT™ ODT) in an open-label fashion and those weighing 40 kg and above received a 10 mg dose of rizatriptan benzoate (Maxalt-MLT™ ODT) in an open-label fashion with the specific dose determined by the participant's weight at predose on Day 1. Participants were to fast from all food and drink except water for 1 hour prior to dose administration. To clear the palate and wet the oral mucosa, 120 mL of water was administered 5 minutes prior to dose administration. Subsequently, the investigator (or representative) provided each participant with the study drug tablet at weight-based dose with verbal instructions to close their mouth and not swallow the tablet allowing it to dissolve on their tongue. When they felt it had disappeared from their tongue, they were then permitted to swallow it.

    Number of subjects in period 1
    		Rizatriptan benzoate ODT
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rizatriptan benzoate ODT
    Reporting group description
    		 Subjects were administered a single dose of either 5-mg or 10-mg rizatriptan benzoate ODT in open label fashion with the specific dose determined by the subject’s weight at predose on Day 1.

    Reporting group values
    		 Rizatriptan benzoate ODT Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        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)
    		 12 12
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 8.8 (6 to 11) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    Rizatriptan benzoate ODT
    Reporting group description
    		 Subjects were administered a single dose of either 5-mg or 10-mg rizatriptan benzoate ODT in open label fashion with the specific dose determined by the subject’s weight at predose on Day 1.

    Subject analysis set title
    Rizatriptan benzoate ODT 10 mg
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received rizatriptan benzoate ODT 10 mg.

    Subject analysis set title
    Rizatriptan benzoate ODT 5 mg
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received rizatriptan benzoate ODT 5 mg.

    Primary: Rizatriptan Palatability (Overall)

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    End point title
    		 Rizatriptan Palatability (Overall) [1]
    End point description
    A palatability taste test assessment was performed in the immediate moments (5 minutes) after challenge with the rizatriptan benzoate ODT. Five minutes after dose administration, the subjects were queried for taste with a specific, standardized question and the participant's response was recorded with a validated 5-point facial hedonic scale with matching descriptive labels (Very Bad=1; Bad=2; Average=3; Good=4; Very Good=5).
    End point type
    Primary
    End point timeframe
    At 5 minutes after oral challenge with rizatriptan (Maxalt-MLT™ ODT) 5 mg and 10 mg.
    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: Per protocol only summary statistics for palatability scores based on the 5 point hedonic scale were to be provided.
    End point values
    		 Rizatriptan benzoate ODT
    Number of subjects analysed
    12
    Units: Taste Score Responses
        Very Bad (1)
    3
        Bad (2)
    2
        Average (3)
    2
        Good (4)
    4
        Very Good (5)
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse experiences (AEs) were collected from the time of screening until approximately 14 days after study drug administration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Rizatriptan benzoate ODT 10 mg
    Reporting group description
    		 Subjects were administered a single dose of 10-mg rizatriptan benzoate ODT in open label fashion on Day 1.

    Reporting group title
    Rizatriptan benzoate ODT 5 mg
    Reporting group description
    		 Subjects were administered a single dose of 5-mg rizatriptan benzoate ODT in open label fashion on Day 1.

    Serious adverse events
    		 Rizatriptan benzoate ODT 10 mg Rizatriptan benzoate ODT 5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rizatriptan benzoate ODT 10 mg Rizatriptan benzoate ODT 5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    5 / 9 (55.56%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 3 (66.67%)
    3 / 9 (33.33%)
         occurrences all number
    2
    3
    Migraine
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Facial pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Eosinophil count increased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in jaw
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 9 (0.00%)
         occurrences all number
    1
    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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    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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