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    Clinical Trial Results:
    A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis

    Summary
    EudraCT number
    		 2018-000516-22
    Trial protocol
    		 PT   EE   HU  
    Global end of trial date
    21 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Apr 2023
    First version publication date
    06 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    800MS301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03870763
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biogen
    Sponsor organisation address
    250 Binney Street, Cambridge, United States, 02142
    Public contact
    Study Medical Director, Biogen, clinicaltrials@biogen.com
    Scientific contact
    Study Medical Director, Biogen, clinicaltrials@biogen.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
    21 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jul 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of the study is to evaluate the efficacy and safety of Dimethyl Fumarate (BG00012) and Peginterferon Beta-1a (BIIB017), both compared with placebo, in paediatric subjects with relapsing-remitting multiple sclerosis (RRMS).
    Protection of trial subjects
    Written informed consent was obtained from each subject or subject’s legally authorized representative (e.g., legal guardian), as applicable, prior to evaluations performed for eligibility. Subjects or the subject’s legally authorized representative were given adequate time to review the information in the informed consent/assent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Mar 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
    Estonia: 4
    Country: Number of subjects enrolled
    Tunisia: 2
    Country: Number of subjects enrolled
    Turkey: 2
    Country: Number of subjects enrolled
    Jordan: 2
    Country: Number of subjects enrolled
    Taiwan: 1
    Worldwide total number of subjects
    11
    EEA total number of subjects
    4
    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)
    11
    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
    		 Subjects were enrolled at the investigative sites in Estonia, Tunisia, Turkey, Jordan and Taiwan from 19 March 2019 to 21 July 2022.

    Pre-assignment
    Screening details
    		 A total of 11 subjects were enrolled and treated in the study.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dimethyl Fumarate 240 mg
    Arm description
    		 Subjects received dimethyl fumarate 120 milligrams (mg) capsules twice daily (BID), orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo subcutaneous (SC) injection once every 2 weeks (Q2W) for up to 96 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dimethyl Fumarate
    Investigational medicinal product code
    Other name
    BG00012
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Dimethyl fumarate 120 mg capsules, BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks.

    Investigational medicinal product name
    Peginterferon beta-1a matching placebo
    Investigational medicinal product code
    Other name
    BIIB017
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon beta-1a matching placebo Q2W for up to 96 weeks.

    Arm title
    		 Peginterferon Beta-1a 125 µg
    Arm description
    		 Subjects received peginterferon beta-1a, 63 micrograms (µg) on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peginterferon beta-1a matching placebo
    Investigational medicinal product code
    Other name
    BIIB017
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon beta-1a matching placebo Q2W for up to 96 weeks.

    Investigational medicinal product name
    peginterferon beta-1a
    Investigational medicinal product code
    Other name
    BIIB017
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon beta-1a, 63 µg on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Capsule
    Routes of administration
    Subcutaneous use, Oral use
    Dosage and administration details
    Peginterferon beta-1a matching placebo SC injection, Q2W and dimethyl fumarate matching placebo capsules, BID, orally for up to 96 weeks.

    Number of subjects in period 1
    		Dimethyl Fumarate 240 mg Peginterferon Beta-1a 125 µg Placebo
    Started
    2
    6
    3
    Completed
    2
    3
    2
    Not completed
    0
    3
    1
         Consent withdrawn by subject
    -
    1
    -
         Worsening of multiple sclerosis attack
    -
    -
    1
         Study terminated by sponsor
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dimethyl Fumarate 240 mg
    Reporting group description
    		 Subjects received dimethyl fumarate 120 milligrams (mg) capsules twice daily (BID), orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo subcutaneous (SC) injection once every 2 weeks (Q2W) for up to 96 weeks.

    Reporting group title
    Peginterferon Beta-1a 125 µg
    Reporting group description
    		 Subjects received peginterferon beta-1a, 63 micrograms (µg) on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.

    Reporting group values
    		 Dimethyl Fumarate 240 mg Peginterferon Beta-1a 125 µg Placebo Total
    Number of subjects
    		 2 6 3
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.5 ± 2.12 15.7 ± 1.51 15.7 ± 1.15 -
    Gender categorical
    Units: Subjects
        Female
    		 1 5 2 8
        Male
    		 1 1 1 3
    Race
    Units: Subjects
        White
    		 2 5 3 10
        Asian
    		 0 1 0 1
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 2 6 3 11

    End points

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    End points reporting groups
    Reporting group title
    Dimethyl Fumarate 240 mg
    Reporting group description
    		 Subjects received dimethyl fumarate 120 milligrams (mg) capsules twice daily (BID), orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo subcutaneous (SC) injection once every 2 weeks (Q2W) for up to 96 weeks.

    Reporting group title
    Peginterferon Beta-1a 125 µg
    Reporting group description
    		 Subjects received peginterferon beta-1a, 63 micrograms (µg) on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.

    Primary: Time to First Relapse

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    End point title
    		 Time to First Relapse [1]
    End point description
    A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. Time to First Relapse is estimated by Kaplan Mayer method. "99999" signifies data is not available as no participant in this arm group had a relapse. ITT population included all subjects who were randomised and received at least 1 dose of study treatment (BG00012, BIIB017, or placebo). The overall number of subjects analysed signifies the number of subjects with relapse.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 96
    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: Only descriptive analysis is planned to be analysed.
    End point values
    		 Dimethyl Fumarate 240 mg Peginterferon Beta-1a 125 µg Placebo
    Number of subjects analysed
    2
    6
    3
    Units: Days
        median (inter-quartile range (Q1-Q3))
    413 (413 to 413)
    99999 (99999 to 99999)
    166.5 (113 to 220)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Safety population included all subjects who had received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 100
    End point values
    		 Dimethyl Fumarate 240 mg Peginterferon Beta-1a 125 µg Placebo
    Number of subjects analysed
    2
    6
    3
    Units: subjects
        AEs
    2
    6
    3
        SAEs
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans at Weeks 48 and 96

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    End point title
    		 Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans at Weeks 48 and 96
    End point description
    The number of new or newly enlarging T2 hyperintense lesions that developed in each subject assessed on magnetic resonance imaging (MRI) scans. The overall number of subjects analysed signifies number of subjects analysed in this endpoint and the number analysed 'n' signifies number of subjects analysed at a given timepoint. ITT population included all subjects who were randomised and received at least 1 dose of study treatment (BG00012, BIIB017, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 48 and 96
    End point values
    		 Dimethyl Fumarate 240 mg Peginterferon Beta-1a 125 µg Placebo
    Number of subjects analysed
    2
    5
    3
    Units: number of lesions
    arithmetic mean (full range (min-max))
        Week 48
    0.5 (0 to 1)
    1.0 (0 to 3)
    3.3 (2 to 4)
        Week 96 (n= 2, 4, 2)
    2.5 (0 to 5)
    1.3 (0 to 3)
    3.5 (2 to 5)
    No statistical analyses for this end point

    Secondary: Number of Galdolinium(Gd)-Enhancing Lesions at Weeks 48 and 96

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    End point title
    		 Number of Galdolinium(Gd)-Enhancing Lesions at Weeks 48 and 96
    End point description
    The number of Gd-enhancing lesions was assessed by using MRI scans. The overall number of subjects analysed signifies number of subjects analysed in this endpoint and the number analysed 'n' signifies number of subjects analysed at a given timepoint. ITT population included all subjects who were randomised and received at least 1 dose of study treatment (BG00012, BIIB017, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 48 and 96
    End point values
    		 Dimethyl Fumarate 240 mg Peginterferon Beta-1a 125 µg Placebo
    Number of subjects analysed
    2
    5
    2
    Units: number of lesions
    arithmetic mean (full range (min-max))
        Week 48
    0 (0 to 0)
    0 (0 to 0)
    1.5 (0 to 3)
        Week 96 (n= 2, 4, 2)
    0 (0 to 0)
    0.25 (0 to 1)
    0.5 (0 to 1)
    No statistical analyses for this end point

    Secondary: Annualized Relapse Rate

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    End point title
    		 Annualized Relapse Rate
    End point description
    A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. The relapse rate for an individual participant was calculated as the number of relapses for that participant divided by the number of participant-years followed. The ARR for each enrolment group was calculated as the total number of relapses experienced in the group divided by the total number of participant-years on the study. An unadjusted relapse rate is reported. ITT population included all subjects who were randomised and received at least 1 dose of study treatment (BG00012, BIIB017, or placebo).
    End point type
    Secondary
    End point timeframe
    up to Week 96
    End point values
    		 Dimethyl Fumarate 240 mg Peginterferon Beta-1a 125 µg Placebo
    Number of subjects analysed
    2
    6
    3
    Units: relapses per subject year
        number (not applicable)
    0.26
    0.00
    0.46
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 100
    Adverse event reporting additional description
    Safety population included all subjects who had received at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Dimethyl Fumarate 240 mg
    Reporting group description
    		 Subjects received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received peginterferon beta-1a matching placebo SC injection, Q2W and dimethyl fumarate matching placebo capsules, BID, orally for up to 96 weeks.

    Reporting group title
    Peginterferon Beta-1a 125 µg
    Reporting group description
    		 Subjects received peginterferon beta-1a, 63 µg on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.

    Serious adverse events
    		 Dimethyl Fumarate 240 mg Placebo Peginterferon Beta-1a 125 µg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Multiple sclerosis relapse
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dimethyl Fumarate 240 mg Placebo Peginterferon Beta-1a 125 µg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    3 / 3 (100.00%)
    6 / 6 (100.00%)
    Investigations
    Parasite stool test positive
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Vitamin D decreased
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    4 / 6 (66.67%)
         occurrences all number
    1
    7
    14
    Multiple sclerosis relapse
         subjects affected / exposed
    1 / 2 (50.00%)
    2 / 3 (66.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    3
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    2
    Chills
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    2
    Fatigue
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    Feeling cold
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    2
    Injection site bruising
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Injection site erythema
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    3
    Diarrhoea
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    7
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Sensitive skin
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Neck pain
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Asymptomatic COVID-19
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    COVID-19
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Vaginal infection
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2018
    a) Excluded the subjects who had a low lymphocyte count following study withdrawal/completion from further follow-up, should they be initiated on appropriate MS treatment, according to local standard of care. b) Provision of open-label access to BG00012 (Tecfidera) for subjects who experienced a confirmed relapse at any point during the study or who had a high lesion burden on MRI at Week 48 until the end of their scheduled participation in the study if considered suitable by the treating neurologist.
    09 Aug 2018
    Clarified the level of detail and purpose of date-of-birth (DOB) information collected for the subjects enrolled in the study.
    06 Nov 2019
    Adjusted the sample sizes of the study populations.

    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.
    The study was terminated because of long-term difficulties in fulfilling the enrolment commitments and changes in paediatric MS landscape which no longer support placebo-controlled trials. Decision to stop study was not based on safety concerns.
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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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