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    Clinical Trial Results:
    A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine

    Summary
    EudraCT number
    		 2019-002603-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2020
    First version publication date
    30 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H8H-MC-LAHX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03988088
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16932
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002166-PIP01-17
    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
    24 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine. The study will last about 6 weeks, and includes 4 visits.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jul 2019
    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
    United States: 10
    Country: Number of subjects enrolled
    Japan: 8
    Worldwide total number of subjects
    18
    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)
    6
    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
    		 No Text Available

    Pre-assignment
    Screening details
    		 No Text Available

    Period 1
    Period 1 title
    Single-Dose Pharmacokinetic Study
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 100 mg Lasmiditan
    Arm description
    		 Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lasmiditan
    Investigational medicinal product code
    Other name
    LY573144
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received single oral dose of 100 mg Lasmiditan.

    Arm title
    		 200 mg Lasmiditan
    Arm description
    		 Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lasmiditan
    Investigational medicinal product code
    Other name
    LY573144
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received single oral dose of 200 mg Lasmiditan.

    Number of subjects in period 1
    		100 mg Lasmiditan 200 mg Lasmiditan
    Started
    11
    7
    Completed
    11
    6
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1
    Period 2
    Period 2 title
    Open-Label Addendum
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 50 mg Lasmiditan-Addendum
    Arm description
    		 Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lasmiditan
    Investigational medicinal product code
    Other name
    LY573144
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received single oral dose of 50 mg Lasmiditan.

    Arm title
    		 100 mg Lasmiditan-Addendum
    Arm description
    		 Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lasmiditan
    Investigational medicinal product code
    Other name
    LY573144
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received single oral dose of 100 mg Lasmiditan.

    Number of subjects in period 2 [1]
    		50 mg Lasmiditan-Addendum 100 mg Lasmiditan-Addendum
    Started
    2
    2
    Completed
    1
    2
    Not completed
    1
    0
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The US participants had the option to enter this optional 3-month open-label extension addendum.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    100 mg Lasmiditan
    Reporting group description
    		 Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.

    Reporting group title
    200 mg Lasmiditan
    Reporting group description
    		 Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.

    Reporting group values
    		 100 mg Lasmiditan 200 mg Lasmiditan Total
    Number of subjects
    		 11 7 18
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.09 ( 2.02 ) 14.00 ( 2.65 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6 12
        Male
    		 5 1 6
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 1 2
        Not Hispanic or Latino
    		 5 3 8
        Unknown or Not Reported
    		 5 3 8
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 5 3 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 5 1 6
        White
    		 1 3 4
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        United States
    		 6 4 10
        Japan
    		 5 3 8

    End points

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    End points reporting groups
    Reporting group title
    100 mg Lasmiditan
    Reporting group description
    		 Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.

    Reporting group title
    200 mg Lasmiditan
    Reporting group description
    		 Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
    Reporting group title
    50 mg Lasmiditan-Addendum
    Reporting group description
    		 Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan.

    Reporting group title
    100 mg Lasmiditan-Addendum
    Reporting group description
    		 Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan.

    Primary: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan

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    End point title
    		 Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan [1]
    End point description
    Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable PK data.
    End point type
    Primary
    End point timeframe
    0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
    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 inferential statistics were planned for this endpoint.
    End point values
    		 100 mg Lasmiditan 200 mg Lasmiditan
    Number of subjects analysed
    11
    7
    Units: nanograms per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    362 ( 46.7 )
    426 ( 43.5 )
    No statistical analyses for this end point

    Primary: PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan

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    End point title
    		 PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan [2]
    End point description
    PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable PK data.
    End point type
    Primary
    End point timeframe
    0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
    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 inferential statistics were planned for this endpoint.
    End point values
    		 100 mg Lasmiditan 200 mg Lasmiditan
    Number of subjects analysed
    11
    6
    Units: nanograms*hours per milliliter(ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    2050 ( 38.4 )
    2590 ( 13.7 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    H8H-MC-LAHX
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    100 mg Lasmiditan
    Reporting group description
    		 -

    Reporting group title
    200 mg Lasmiditan
    Reporting group description
    		 -

    Reporting group title
    50 mg Lasmiditan-Addendum
    Reporting group description
    		 -

    Reporting group title
    100 mg Lasmiditan-Addendum
    Reporting group description
    		 -

    Serious adverse events
    		 100 mg Lasmiditan 200 mg Lasmiditan 50 mg Lasmiditan-Addendum 100 mg Lasmiditan-Addendum
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 100 mg Lasmiditan 200 mg Lasmiditan 50 mg Lasmiditan-Addendum 100 mg Lasmiditan-Addendum
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 11 (27.27%)
    5 / 7 (71.43%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    Nervous system disorders
    ataxia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 7 (28.57%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    0
    disturbance in attention
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    dizziness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 7 (57.14%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    5
    0
    0
    somnolence
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    fatigue
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 7 (42.86%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    4
    0
    2
    Eye disorders
    lacrimation increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    nausea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    confusional state
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    irritability
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    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
    For support, Contact us.
    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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