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    Clinical Trial Results:
    A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS)

    Summary
    EudraCT number
    		 2014-001643-20
    Trial protocol
    		 DE   PL   SE  
    Global end of trial date
    06 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2017
    First version publication date
    22 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DRI13839
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02222948
    WHO universal trial number (UTN)
    		 U1111-1153-3840
    Other trial identifiers
    		 Study name: EMPIRE
    Sponsors
    Sponsor organisation name
    Genzyme Corporation
    Sponsor organisation address
    500 Kendall Street, Cambridge, MA, United States, 02142
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    27 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Apr 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    -To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in Relapsing-Remitting Multiple Sclerosis (RRMS) subjects; and -To evaluate mutiple doses of vatelizumab for a dose-response.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Sep 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 23 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 39
    Country: Number of subjects enrolled
    Russian Federation: 54
    Country: Number of subjects enrolled
    United States: 17
    Country: Number of subjects enrolled
    Canada: 2
    Worldwide total number of subjects
    112
    EEA total number of subjects
    39
    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)
    0
    Adults (18-64 years)
    112
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 21 sites in 4 countries from 23 September 2014 to 06 April 2016. A total of 183 subjects were screened, of whom, 112 randomized in the study. Based on the results of an interim analysis, a decision was made to discontinue study treatment as per Sponsor’s decision, which was notified to all investigators in October 2015.

    Pre-assignment
    Screening details
    		 First 48 subjects were randomized in 1:1 ratio to placebo or vatelizumab 1600 mg. After randomization of 48th subject, additional 120 subjects were to be randomized which was not completed based on results of an interim analysis and only 64 additional subjects randomized to vatelizumab 1600 mg,1200 mg,800 mg,400 mg or placebo in 1:1:1:1:1 ratio.

    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
    		 Investigator, Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo (for vatelizumab) intravenous (IV) infusion at Week 0, 2, 4, and 8.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (for Vatelizumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion over a 60 minutes period.

    Arm title
    		 Vatelizumab 1600 mg
    Arm description
    		 Vatelizumab 1600 mg IV infusion at Week 0, 2, 4, and 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vatelizumab
    Investigational medicinal product code
    SAR339658
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion over a 60 minutes period.

    Arm title
    		 Vatelizumab 1200 mg
    Arm description
    		 Vatelizumab 1200 mg IV infusion at Week 0, 2, 4, and 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vatelizumab
    Investigational medicinal product code
    SAR339658
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion over a 60 minutes period.

    Arm title
    		 Vatelizumab 800 mg
    Arm description
    		 Vatelizumab 800 mg IV infusion at Week 0, 2, 4, and 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vatelizumab
    Investigational medicinal product code
    SAR339658
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion over a 60 minutes period.

    Arm title
    		 Vatelizumab 400 mg
    Arm description
    		 Vatelizumab 400 mg IV infusion at Week 0, 2, 4, and 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vatelizumab
    Investigational medicinal product code
    SAR339658
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion over a 60 minutes period.

    Number of subjects in period 1
    		Placebo Vatelizumab 1600 mg Vatelizumab 1200 mg Vatelizumab 800 mg Vatelizumab 400 mg
    Started
    38
    36
    13
    12
    13
    Completed
    27
    30
    6
    6
    6
    Not completed
    11
    6
    7
    6
    7
         Consent withdrawn by subject
    3
    5
    3
    3
    5
         Study terminated by sponsor
    7
    1
    4
    2
    2
         Other than specified
    -
    -
    -
    1
    -
         Lost to follow-up
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (for vatelizumab) intravenous (IV) infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 1600 mg
    Reporting group description
    		 Vatelizumab 1600 mg IV infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 1200 mg
    Reporting group description
    		 Vatelizumab 1200 mg IV infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 800 mg
    Reporting group description
    		 Vatelizumab 800 mg IV infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 400 mg
    Reporting group description
    		 Vatelizumab 400 mg IV infusion at Week 0, 2, 4, and 8.

    Reporting group values
    		 Placebo Vatelizumab 1600 mg Vatelizumab 1200 mg Vatelizumab 800 mg Vatelizumab 400 mg Total
    Number of subjects
    		 38 36 13 12 13 112
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.4 ( 9.08 ) 33.6 ( 10.02 ) 32.4 ( 6.38 ) 34.5 ( 8.04 ) 34.2 ( 9.42 ) -
    Gender categorical
    Units: Subjects
        Female
    		 27 23 8 5 9 72
        Male
    		 11 13 5 7 4 40

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (for vatelizumab) intravenous (IV) infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 1600 mg
    Reporting group description
    		 Vatelizumab 1600 mg IV infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 1200 mg
    Reporting group description
    		 Vatelizumab 1200 mg IV infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 800 mg
    Reporting group description
    		 Vatelizumab 800 mg IV infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 400 mg
    Reporting group description
    		 Vatelizumab 400 mg IV infusion at Week 0, 2, 4, and 8.

    Primary: Brain Magnetic Resonance Imaging (MRI) Assessment: Cumulative Number of New T1 Gadolinium (Gd) Contrast-Enhancing Lesions (CELs) Per MRI Scan

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    End point title
    		 Brain Magnetic Resonance Imaging (MRI) Assessment: Cumulative Number of New T1 Gadolinium (Gd) Contrast-Enhancing Lesions (CELs) Per MRI Scan [1]
    End point description
    Cumulative number of Gd-enhancing T1-lesions per MRI scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. Analysis was performed on safety population defined as randomized population who actually received at least 1 dose or part of a dose of study drug analyzed according to the treatment actually received. Here, 'n' signifies number of subjects with available data for specified timepoints.
    End point type
    Primary
    End point timeframe
    Week 4, Week 8 and Week 12 (End of Treatment [EOT]) (maximum exposure: 62 days)
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 Placebo Vatelizumab 1600 mg Vatelizumab 1200 mg Vatelizumab 800 mg Vatelizumab 400 mg
    Number of subjects analysed
    38
    36
    13
    12
    13
    Units: lesions per scan
    arithmetic mean (standard deviation)
        Week 4 (n= 33, 34, 11, 10, 11)
    2.8 ( 5.41 )
    2 ( 2.65 )
    5.3 ( 8.7 )
    3.2 ( 3.43 )
    1.8 ( 2.64 )
        Week 8 (n= 30, 32, 8, 8, 8)
    4.8 ( 8.08 )
    3.3 ( 4.99 )
    14.8 ( 16.86 )
    3.8 ( 3.92 )
    1.6 ( 2.77 )
        Week 12 (EOT [n= 26, 30, 7, 6, 5])
    8.1 ( 12.25 )
    5.5 ( 7.4 )
    21.1 ( 39.21 )
    6.8 ( 6.62 )
    1 ( 2.24 )
    No statistical analyses for this end point

    Primary: Brain MRI Assessment: Cumulative Number of New or Newly Enlarging T2 Lesions per MRI Scan

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    End point title
    		 Brain MRI Assessment: Cumulative Number of New or Newly Enlarging T2 Lesions per MRI Scan [2]
    End point description
    Number of Gd-enhancing T2-lesions per scan is the total number of Gd-enhancing T2-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. Analysis was performed on safety population. Here, 'n' signifies number of subjects with available data for specified timepoints.
    End point type
    Primary
    End point timeframe
    Week 4, Week 8 and Week 12 (EOT) (maximum exposure: 62 days)
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 Placebo Vatelizumab 1600 mg Vatelizumab 1200 mg Vatelizumab 800 mg Vatelizumab 400 mg
    Number of subjects analysed
    38
    36
    13
    12
    13
    Units: lesions per scan
    arithmetic mean (standard deviation)
        Week 4 (n= 33, 34, 11, 10, 11)
    3.5 ( 6.3 )
    2.9 ( 3.37 )
    6.5 ( 9.23 )
    4.7 ( 5.83 )
    2.7 ( 3.58 )
        Week 8 (n= 30, 32, 8, 8, 8)
    6.4 ( 9.94 )
    6 ( 8.25 )
    15.8 ( 17.79 )
    5.4 ( 5.18 )
    2.8 ( 4.2 )
        Week 12 (EOT [n= 26, 30, 7, 6, 5])
    10.2 ( 14.29 )
    7.9 ( 9.58 )
    21.4 ( 36.57 )
    8.7 ( 8.38 )
    2 ( 3.94 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Serum Concentration of Vatelizumab

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    End point title
    		 Pharmacokinetics: Serum Concentration of Vatelizumab [3]
    End point description
    Blood samples were collected for determination of serum vatelizumab concentration at Week 0, 2, 4 and 8 prior to the start of infusion and at the end of infusion. A single PK sample was collected at Week 12 (all subjects) and Week 14, 20, and 32 (subjects not participating in separate extension study). Analysis was performed on safety population. Here, 'n' signifies number of subjects with available data for specified timepoints.
    End point type
    Secondary
    End point timeframe
    Week 0, 2, 4, 8 (pre-dose and any time after the end of infusion); Week 12, 14, 20 and Week 32 (anytime)
    Notes
    [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: The endpoint was planned to be analyzed only for vatelizumab, and not for placebo.
    End point values
    		 Vatelizumab 1600 mg Vatelizumab 1200 mg Vatelizumab 800 mg Vatelizumab 400 mg
    Number of subjects analysed
    36
    13
    12
    13
    Units: μg/mL
    arithmetic mean (standard deviation)
        Week 0:predose (n=36,13,12,13)
    12.5 ( 75.13 )
    0.1 ( 0.34 )
    0 ( 0 )
    0 ( 0 )
        Week 0:after the end of infusion (n=36,13,12,13)
    478.4 ( 148.33 )
    363 ( 123.26 )
    248.9 ( 46.59 )
    123.8 ( 24.54 )
        Week 2:predose (n=35,11,10,11)
    121 ( 28.1 )
    106.7 ( 21.13 )
    59.3 ( 14.08 )
    23 ( 10.95 )
        Week 2:after the end of infusion (n=35,10,9,11)
    595.8 ( 124.47 )
    440.9 ( 77.01 )
    284.7 ( 42.61 )
    137.3 ( 35.11 )
        Week 4:predose (n=33,10,8,9)
    198.5 ( 46.12 )
    181.7 ( 71.9 )
    106.2 ( 26.65 )
    45.1 ( 24.34 )
        Week 4:after the end of infusion (n=33,10,8,9)
    657.4 ( 128.34 )
    512.6 ( 86.56 )
    325.2 ( 50.14 )
    163.9 ( 46.13 )
        Week 8:predose (n=30,6,6,6)
    154.1 ( 49.38 )
    126.5 ( 46.58 )
    82.2 ( 29.87 )
    22.9 ( 7.23 )
        Week 8:after the end of infusion (n=29,6,6,6)
    579.9 ( 176.2 )
    493.4 ( 87.59 )
    323.6 ( 47.36 )
    134.7 ( 20.89 )
        Week 12:(n=35,13,12,12)
    130.6 ( 50.52 )
    136.3 ( 57 )
    74.6 ( 22.81 )
    30.7 ( 20.67 )
        Week 14:post-treatment (n=6,7,4,4)
    64.1 ( 23.57 )
    68.6 ( 44.62 )
    28.7 ( 12.38 )
    9.9 ( 4.02 )
        Week 20:post-treatment (n= 3, 4, 5, 4)
    5.3 ( 6.51 )
    7 ( 4.59 )
    2 ( 1.4 )
    2.4 ( 3.74 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 104) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (time from the first administration of study drug to the end of the safety follow-up period [Week 104]).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (for vatelizumab) IV infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 1600 mg
    Reporting group description
    		 Vatelizumab 1600 mg IV infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 1200 mg
    Reporting group description
    		 Vatelizumab 1200 mg IV infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 800 mg
    Reporting group description
    		 Vatelizumab 800 mg IV infusion at Week 0, 2, 4, and 8.

    Reporting group title
    Vatelizumab 400 mg
    Reporting group description
    		 Vatelizumab 400 mg IV infusion at Week 0, 2, 4, and 8.

    Serious adverse events
    		 Placebo Vatelizumab 1600 mg Vatelizumab 1200 mg Vatelizumab 800 mg Vatelizumab 400 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Reproductive system and breast disorders
    Ovarian Cyst
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Vatelizumab 1600 mg Vatelizumab 1200 mg Vatelizumab 800 mg Vatelizumab 400 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 38 (34.21%)
    9 / 36 (25.00%)
    2 / 13 (15.38%)
    3 / 12 (25.00%)
    3 / 13 (23.08%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    2
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    0
    0
    1
    Infusion Related Reaction
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 36 (2.78%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 38 (13.16%)
    5 / 36 (13.89%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    5
    5
    1
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 36 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Gastritis Erosive
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 36 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Endocrine disorders
    Autoimmune Thyroiditis
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Oral Herpes
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 36 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    0
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 36 (2.78%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Feb 2015
    Amendment 1 addresses the following changes: •Modified treatment discontinuation criteria: changed the threshold from >10 to >8 new CELs and/or new/newly enlarging T2 lesions for assessing MS disease activity on MRI scan:For subjects who developed more than 8 new CELs and/or 8 new/newly enlarging T2 lesions instead of 10 new CELs and/or 10 new/newly enlarging T2 lesions on any MRI scan after the second infusion of IMP, the Investigator was advised to review the subject’s disease status and consider withdrawing the subject from study treatment and starting an approved MS therapy. The central MRI reader would notified the Investigator, study coordinator, and Sponsor when a subject had met these MRI criteria. •Correct description of collection of informed consent for optional extension study at Week 8: Informed consent to be obtained prior to enrolment in the extension study and to be detailed in that protocol only. •Updated text regarding extension study. •Provided additional information regarding acquisition of MRI scan. •Corrected and clarified typos, inconsistencies throughout the protocol.

    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.
    As per sponsor’s decision, the study was discontinued in October 2015 based on planned interim analysis of the primary endpoint. Not linked to any safety concern.
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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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