Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Open-label, Single-dose, Pharmacokinetic Study to Evaluate IV Eptinezumab in Children and Adolescents with Migraine, Followed by an Optional, Multiple-dose, Open-label Extension Period

    Summary
    EudraCT number
    		 2022-004102-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    15 Apr 2023
    First version publication date
    15 Apr 2023
    Other versions
    		 v2 , v3

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    18922A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04537429
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002243-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?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    20 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Oct 2022
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to characterize the pharmacokinetics (PK) profile of eptinezumab after a single intravenous (IV) administration in pediatric participants 6 to 17 years of age.
    Protection of trial subjects
    This study is being conducted in compliance with Good Clinical Practice and in accordance with the ethical principles described in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Aug 2020
    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: 28
    Worldwide total number of subjects
    28
    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)
    16
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study consists of a single-dose, 20-week Main Study Period (Part A) and an optional 44-week multiple-dose Extension Period (Part B). The data collected during the completed Main Study Period (Part A) are presented. The data from the ongoing Extension Period (Part B) will be presented when the study has been completed.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eptinezumab (Age Group 6 to 11 Years)
    Arm description
    		 Participants received a single dose of eptinezumab on Day 1 based on the highest target adult exposure of eptinezumab, adjusted for the participant's body weight.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eptinezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eptinezumab will be administered per schedule specified in the arm description.

    Arm title
    		 Eptinezumab (Age Group 12 to 17 Years)
    Arm description
    		 Participants received a single dose of eptinezumab on Day 1 based on the highest target adult exposure of eptinezumab, adjusted for the participant's body weight.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eptinezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eptinezumab will be administered per schedule specified in the arm description.

    Number of subjects in period 1
    		Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Started
    12
    16
    Received at least 1 dose of study drug
    12
    16
    Completed
    11
    14
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    -
         Other than specified
    -
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Eptinezumab (Age Group 6 to 11 Years)
    Reporting group description
    		 Participants received a single dose of eptinezumab on Day 1 based on the highest target adult exposure of eptinezumab, adjusted for the participant's body weight.

    Reporting group title
    Eptinezumab (Age Group 12 to 17 Years)
    Reporting group description
    		 Participants received a single dose of eptinezumab on Day 1 based on the highest target adult exposure of eptinezumab, adjusted for the participant's body weight.

    Reporting group values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years) Total
    Number of subjects
    		 12 16 28
    Age Categorical
    Units: Subjects
        Children (2-11 years)
    		 12 0 12
        Adolescents (12-17 years)
    		 0 16 16
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.3 ( 1.97 ) 15.1 ( 1.41 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 10 10 20
        Male
    		 2 6 8
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 5 6
        Not Hispanic or Latino
    		 11 11 22
    Race
    Units: Subjects
        Asian
    		 1 0 1
        Black or African American
    		 1 1 2
        White or Caucasian
    		 9 15 24
        Other
    		 1 0 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Eptinezumab (Age Group 6 to 11 Years)
    Reporting group description
    		 Participants received a single dose of eptinezumab on Day 1 based on the highest target adult exposure of eptinezumab, adjusted for the participant's body weight.

    Reporting group title
    Eptinezumab (Age Group 12 to 17 Years)
    Reporting group description
    		 Participants received a single dose of eptinezumab on Day 1 based on the highest target adult exposure of eptinezumab, adjusted for the participant's body weight.

    Primary: Part A: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Eptinezumab

    		 Close Top of page
    End point title
    		 Part A: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Eptinezumab [1]
    End point description
    PK Part A set (PKS_A) included all treated participants in Part A with at least 1 post-infusion PK sample in Part A. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable for specified category. '99999' signifies 'data not available since no participants were evaluable in that category'. '9999' signifies 'due to single participant, geometric coefficient of variation data could not be calculated'.
    End point type
    Primary
    End point timeframe
    Day 1 (the day of infusion) through Week 20
    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: The statistical analysis was not planned for this endpoint.
    End point values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Number of subjects analysed
    10
    15
    Units: hours*micrograms (µg)/milliliter (mL)
    geometric mean (geometric coefficient of variation)
        Weight Group >20 kg - <=40 kg (n=10,0)
    87780 ( 33.1 )
    99999 ( 99999 )
        Weight Group >40 kg (n=1,15)
    141700 ( 9999 )
    91520 ( 15.1 )
    No statistical analyses for this end point

    Primary: Part A: Maximum Observed Plasma Concentration (Cmax) of Eptinezumab

    		 Close Top of page
    End point title
    		 Part A: Maximum Observed Plasma Concentration (Cmax) of Eptinezumab [2]
    End point description
    PKS_A included all treated participants in Part A with at least 1 post-infusion PK sample in Part A. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable for specified category. '99999' signifies 'data not available since no participants were evaluable in that category'. '9999' signifies 'due to single participant, geometric coefficient of variation data could not be calculated'.
    End point type
    Primary
    End point timeframe
    Day 1 (the day of infusion) through Week 20
    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: The statistical analysis was not planned for this endpoint.
    End point values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Number of subjects analysed
    11
    16
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Weight Group >20 kg - <=40 kg (n=11,0)
    126.2 ( 31.9 )
    99999 ( 99999 )
        Weight Group >40 kg (n=1,16)
    215.7 ( 9999 )
    129.7 ( 32.4 )
    No statistical analyses for this end point

    Secondary: Part A: Area Under the Concentration Versus Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t last) of Eptinezumab

    		 Close Top of page
    End point title
    		 Part A: Area Under the Concentration Versus Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t last) of Eptinezumab
    End point description
    PKS_A included all treated participants in Part A with at least 1 post-infusion PK sample in Part A. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable for specified category. '99999' signifies 'data not available since no participants were evaluable in that category'. '9999' signifies 'due to single participant, geometric coefficient of variation data could not be calculated'.
    End point type
    Secondary
    End point timeframe
    Day 1 (the day of infusion) through Week 20
    End point values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Number of subjects analysed
    11
    16
    Units: hours*µg/mL
    geometric mean (geometric coefficient of variation)
        Weight Group >20 kg - <=40 kg (n=11,0)
    79260 ( 40.6 )
    99999 ( 99999 )
        Weight Group >40 kg (n=1,16)
    138000 ( 9999 )
    86500 ( 15.4 )
    No statistical analyses for this end point

    Secondary: Part A: Concentration for Eptinezumab Determined From the Data Without Interpolation at Week 12 (C12wk)

    		 Close Top of page
    End point title
    		 Part A: Concentration for Eptinezumab Determined From the Data Without Interpolation at Week 12 (C12wk)
    End point description
    PKS_A included all treated participants in Part A with at least 1 post-infusion PK sample in Part A. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable for specified category. '99999' signifies 'data not available since no participants were evaluable in that category'. '9999' signifies 'due to single participant, geometric coefficient of variation data could not be calculated'.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Number of subjects analysed
    10
    15
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Weight Group >20 kg - <=40 kg (n=10,0)
    6.440 ( 117 )
    99999 ( 99999 )
        Weight Group >40 kg (n=1,15)
    13.38 ( 9999 )
    9.502 ( 28.5 )
    No statistical analyses for this end point

    Secondary: Part A: Time to Reach Cmax (tmax) of Eptinezumab

    		 Close Top of page
    End point title
    		 Part A: Time to Reach Cmax (tmax) of Eptinezumab
    End point description
    PKS_A included all treated participants in Part A with at least 1 post-infusion PK sample in Part A. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable for specified category. '99999' signifies 'data not available since no participants were evaluable in that category'.
    End point type
    Secondary
    End point timeframe
    Day 1 (the day of infusion) through Week 20
    End point values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Number of subjects analysed
    11
    16
    Units: hours
    median (inter-quartile range (Q1-Q3))
        Weight Group >20 kg - <=40 kg (n=11,0)
    0.6830 (0.5830 to 2.500)
    99999 (99999 to 99999)
        Weight Group >40 kg (n=1,16)
    2.617 (2.617 to 2.617)
    1.708 (0.6165 to 2.675)
    No statistical analyses for this end point

    Secondary: Part A: Terminal Elimination Half-life (t1/2) of Eptinezumab

    		 Close Top of page
    End point title
    		 Part A: Terminal Elimination Half-life (t1/2) of Eptinezumab
    End point description
    PKS_A included all treated participants in Part A with at least 1 post-infusion PK sample in Part A. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable for specified category. '99999' signifies 'data not available since no participants were evaluable in that category'.
    End point type
    Secondary
    End point timeframe
    Day 1 (the day of infusion) through Week 20
    End point values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Number of subjects analysed
    10
    15
    Units: hours
    median (inter-quartile range (Q1-Q3))
        Weight Group >20 kg - <=40 kg (n=10,0)
    659.5 (584.5 to 729.9)
    99999 (99999 to 99999)
        Weight Group >40 kg (n=1,15)
    697.3 (697.3 to 697.3)
    702.4 (609.2 to 800.0)
    No statistical analyses for this end point

    Secondary: Part A: Plasma Clearance (CL) of Eptinezumab

    		 Close Top of page
    End point title
    		 Part A: Plasma Clearance (CL) of Eptinezumab
    End point description
    PKS_A included all treated participants in Part A with at least 1 post-infusion PK sample in Part A. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable for specified category. '99999' signifies 'data not available since no participants were evaluable in that category'. '9999' signifies 'due to single participant, geometric coefficient of variation data could not be calculated'.
    End point type
    Secondary
    End point timeframe
    Day 1 (the day of infusion) through Week 20
    End point values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Number of subjects analysed
    10
    15
    Units: liters/hour
    geometric mean (geometric coefficient of variation)
        Weight Group >20 kg - <=40 kg (n=10,0)
    0.001709 ( 33.1 )
    99999 ( 99999 )
        Weight Group >40 kg (n=1,15)
    0.002118 ( 9999 )
    0.003278 ( 15.1 )
    No statistical analyses for this end point

    Secondary: Part A: Volume of Distribution (Vz) of Eptinezumab

    		 Close Top of page
    End point title
    		 Part A: Volume of Distribution (Vz) of Eptinezumab
    End point description
    PKS_A included all treated participants in Part A with at least 1 post-infusion PK sample in Part A. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable for specified category. '99999' signifies 'data not available since no participants were evaluable in that category'. '9999' signifies 'due to single participant, geometric coefficient of variation data could not be calculated'.
    End point type
    Secondary
    End point timeframe
    Day 1 (the day of infusion) through Week 20
    End point values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Number of subjects analysed
    10
    15
    Units: liters
    geometric mean (geometric coefficient of variation)
        Weight Group >20 kg - <=40 kg (n=10,0)
    1.591 ( 33.7 )
    99999 ( 99999 )
        Weight Group >40 kg (n=1,15)
    2.130 ( 9999 )
    3.324 ( 25.2 )
    No statistical analyses for this end point

    Secondary: Part A: Number of Participants With Binding Anti-Drug Antibodies (ADAs)

    		 Close Top of page
    End point title
    		 Part A: Number of Participants With Binding Anti-Drug Antibodies (ADAs)
    End point description
    Number of participants with positive ADAs are reported. All-patients-treated in Part A set (APTS_A) included all participants treated with eptinezumab in Part A. Here, 'overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Number of subjects analysed
    11
    14
    Units: participants
    0
    2
    No statistical analyses for this end point

    Secondary: Part A: Number of Participants With Neutralizing Binding ADA (NAb)

    		 Close Top of page
    End point title
    		 Part A: Number of Participants With Neutralizing Binding ADA (NAb)
    End point description
    Number of participants with non-reactive NAbs are reported. APTS_A included all participants treated with eptinezumab in Part A. Here, 'overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 Eptinezumab (Age Group 6 to 11 Years) Eptinezumab (Age Group 12 to 17 Years)
    Number of subjects analysed
    11
    14
    Units: participants
    0
    2
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 20
    Adverse event reporting additional description
    APTS_A included all participants treated with eptinezumab in Part A.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Eptinezumab (Age Group 12 to 17 Years)
    Reporting group description
    		 Participants received a single dose of eptinezumab on Day 1 based on the highest target adult exposure of eptinezumab, adjusted for the participant's body weight.

    Reporting group title
    Eptinezumab (Age Group 6 to 11 Years)
    Reporting group description
    		 Participants received a single dose of eptinezumab on Day 1 based on the highest target adult exposure of eptinezumab, adjusted for the participant's body weight.

    Serious adverse events
    		 Eptinezumab (Age Group 12 to 17 Years) Eptinezumab (Age Group 6 to 11 Years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 12 (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
    		 Eptinezumab (Age Group 12 to 17 Years) Eptinezumab (Age Group 6 to 11 Years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 16 (56.25%)
    7 / 12 (58.33%)
    Investigations
    Blood calcium increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Weight increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Accidental overdose
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Vascular disorders
    Orthostatic hypotension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Migraine
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Eye disorders
    Photopsia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Epistaxis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Anxiety
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Adjustment disorder with depressed mood
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Sleep terror
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Proteinuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Infections and infestations
    COVID-19
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gastroenteritis viral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Influenza
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis streptococcal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Pyuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Vitamin D deficiency
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Hypertriglyceridaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Vitamin B12 deficiency
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2020
    - Added the eDiary and in consequence, added 2 exploratory endpoints related to the eDiary and updated the screening period to 4 weeks. - Inclusion criterion: upper percentile limit of Centers for Disease Control and Prevention growth charts changed from 95th to 97th percentile. - Inclusion criterion: specification of adequate method of contraception. - Added description of potential mitigations due to COVID-19 pandemic. - Added that re-screening of participants for other reasons than safety concerns may be granted. - Updated that use of acute medication was allowed if dose had been stable for ≥2 weeks; minimum required period prior to screening visits reduced from ≥12 to ≥2 weeks.

    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.

    European Medicines Agency © 1995-Sat May 10 08:59:07 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA