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    Clinical Trial Results:
    Effect of MD1003 in chronic visual loss related to optic neuritis in multiple sclerosis: a pivotal randomized double masked placebo controlled study

    Summary
    EudraCT number
    		 2013-002112-27
    Trial protocol
    		 FR   GB  
    Global end of trial date
    01 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2020
    First version publication date
    12 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MD1003CT2013-01MS-ON
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medday pharmaceuticals SA
    Sponsor organisation address
    24-26 rue de la Pépinière, Paris, France, Paris, France, 75008
    Public contact
    Frédéric Sedel, MEDDAY PHARMACEUTICALS,, Medday pharmaceuticals SA, +33 1 80 40 14 40, frederic.sedel@medday-pharma.com
    Scientific contact
    Frédéric Sedel, MEDDAY PHARMACEUTICALS, , Medday pharmaceuticals SA, +33 1 80 40 14 40, frederic.sedel@medday-pharma.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
    01 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the superiority of biotin 300 mg/day over placebo in the visual improvement of patients suffering from chronic visual loss after optic neuritis related to multiple sclerosis
    Protection of trial subjects
    This protocol complied with the principal laid down by the 18th World Medical Assembly (Helsinki, 1964 an following amendments) and all applicable amendments laid down by the World Medical Assemblies, as well as the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. The trial complied with the laws and regulations of the country in which the study was performed, and any applicable guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Oct 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 54 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    France: 89
    Worldwide total number of subjects
    93
    EEA total number of subjects
    93
    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)
    92
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 no specific requirements

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 117 [1]
    Number of subjects completed
    		 93

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 inclusion/exclusion criteria: 24
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: the difference is the number of screen failures
    Period 1
    Period 1 title
    Double Blind (M0-M6)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MD1003
    Arm description
    		 MD1003
    Arm type
    		 Experimental

    Investigational medicinal product name
    MD1003
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300mg / day ( 100mg 3 times day - tid)

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300mg / day ( 100mg 3 times day - tid)

    Number of subjects in period 1
    		MD1003 Placebo
    Started
    65
    28
    Completed
    64
    28
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -
    Period 2
    Period 2 title
    Extension Phase (M6 - M66)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 MD1003
    Arm description
    		 MD1003
    Arm type
    		 Experimental

    Investigational medicinal product name
    MD1003
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300mg a day

    Number of subjects in period 2
    		MD1003
    Started
    92
    Completed
    65
    Not completed
    27
         Consent withdrawn by subject
    5
         Physician decision
    5
         Adverse event, non-fatal
    2
         other
    13
         Lack of efficacy
    1
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MD1003
    Reporting group description
    		 MD1003

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 MD1003 Placebo Total
    Number of subjects
    		 65 28 93
    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)
    		 41.6 ( 10.5 ) 41.1 ( 10.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 35 15 50
        Male
    		 30 13 43

    End points

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    End points reporting groups
    Reporting group title
    MD1003
    Reporting group description
    		 MD1003

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo
    Reporting group title
    MD1003
    Reporting group description
    		 MD1003

    Primary: Change from baseline of the best corrected visual acuity at 100% contrast

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    End point title
    		 Change from baseline of the best corrected visual acuity at 100% contrast
    End point description
    Best corrected visual acuity using the ETDRS logMar chart at 100% contrast
    End point type
    Primary
    End point timeframe
    M0-M6
    End point values
    		 MD1003 Placebo
    Number of subjects analysed
    64
    28
    Units: percentage of corrected visual acuity
        arithmetic mean (standard deviation)
    -0.061 ( 0.206 )
    -0.036 ( 0.184 )
    Statistical analysis title
    		 MeanChange in Log Mar
    Comparison groups
    MD1003 v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7487
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Number of Patients With Improved Visual Acuity From Baseline

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    End point title
    		 Number of Patients With Improved Visual Acuity From Baseline
    End point description
    End point type
    Secondary
    End point timeframe
    M0-M6
    End point values
    		 MD1003 Placebo
    Number of subjects analysed
    65
    28
    Units: patients
    6
    2
    No statistical analyses for this end point

    Secondary: Optical Coherence Tomography

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    End point title
    		 Optical Coherence Tomography
    End point description
    End point type
    Secondary
    End point timeframe
    M0-M6
    End point values
    		 MD1003 Placebo
    Number of subjects analysed
    65
    28
    Units: micrometer
        arithmetic mean (standard deviation)
    -0.5 ( 2.6 )
    -0.3 ( 2.7 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    M0-M66
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    MD1003 double blind
    Reporting group description
    		 MD1003

    Reporting group title
    Placebo double blind
    Reporting group description
    		 Placebo

    Reporting group title
    MD1003 extension phase
    Reporting group description
    		 -

    Reporting group title
    Placebo extension phase
    Reporting group description
    		 -

    Serious adverse events
    		 MD1003 double blind Placebo double blind MD1003 extension phase Placebo extension phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 65 (13.85%)
    3 / 28 (10.71%)
    21 / 64 (32.81%)
    12 / 28 (42.86%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    0 / 64 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    0 / 64 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Colectomy
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 28 (3.57%)
    0 / 64 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchidectomy
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shoulder operation
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroidectomy
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urostomy
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Multiple sclerosis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 28 (3.57%)
    2 / 64 (3.13%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis relapse
         subjects affected / exposed
    9 / 65 (13.85%)
    1 / 28 (3.57%)
    11 / 64 (17.19%)
    10 / 28 (35.71%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 1
    2 / 14
    3 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    0 / 64 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    0 / 64 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Condition aggravated
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Discomfort
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal artery occlusion
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 28 (0.00%)
    0 / 64 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 28 (0.00%)
    0 / 64 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 28 (3.57%)
    0 / 64 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MD1003 double blind Placebo double blind MD1003 extension phase Placebo extension phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 65 (41.54%)
    17 / 28 (60.71%)
    47 / 64 (73.44%)
    20 / 28 (71.43%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    3 / 28 (10.71%)
         occurrences all number
    0
    0
    1
    3
    Cardiac disorders
    Oedema peripheral
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    2 / 28 (7.14%)
         occurrences all number
    0
    0
    1
    2
    Nervous system disorders
    Multiple sclerosis relapse
         subjects affected / exposed
    9 / 65 (13.85%)
    1 / 28 (3.57%)
    13 / 64 (20.31%)
    11 / 28 (39.29%)
         occurrences all number
    9
    1
    16
    17
    Headache
         subjects affected / exposed
    3 / 65 (4.62%)
    3 / 28 (10.71%)
    4 / 64 (6.25%)
    4 / 28 (14.29%)
         occurrences all number
    3
    3
    4
    5
    Multiple sclerosis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    4 / 64 (6.25%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    5
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 65 (3.08%)
    2 / 28 (7.14%)
    3 / 64 (4.69%)
    2 / 28 (7.14%)
         occurrences all number
    2
    7
    3
    2
    Dizziness
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 28 (7.14%)
    0 / 64 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 28 (7.14%)
    0 / 64 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Gastrointestinal disorders
    Gastroenteritis
         subjects affected / exposed
    1 / 65 (1.54%)
    3 / 28 (10.71%)
    0 / 64 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    4
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    9 / 64 (14.06%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    11
    2
    Nasopharyngitis
         subjects affected / exposed
    8 / 65 (12.31%)
    1 / 28 (3.57%)
    6 / 64 (9.38%)
    0 / 28 (0.00%)
         occurrences all number
    8
    1
    9
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    0 / 64 (0.00%)
    4 / 28 (14.29%)
         occurrences all number
    0
    0
    0
    5
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    2 / 28 (7.14%)
         occurrences all number
    0
    0
    1
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 28 (7.14%)
    1 / 64 (1.56%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2
    1
    2
    Depressive symptom
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    2 / 28 (7.14%)
         occurrences all number
    0
    0
    1
    2
    Musculoskeletal and connective tissue disorders
    Ligament sprain
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    1 / 64 (1.56%)
    2 / 28 (7.14%)
         occurrences all number
    0
    0
    1
    3
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 65 (6.15%)
    1 / 28 (3.57%)
    5 / 64 (7.81%)
    1 / 28 (3.57%)
         occurrences all number
    4
    1
    10
    1
    Influenza
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 28 (0.00%)
    2 / 64 (3.13%)
    2 / 28 (7.14%)
         occurrences all number
    0
    0
    2
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Sep 2013
    100mg dose arm replaced by 300mg dose arm (due to first efficacy results) in accordance with ANSM/EMA. Addition of one investigator site (Pr Alain Vighetto).
    22 Jan 2014
    Modification of the primary endpoint in accordance with CHMP/SAWG/EMA. Enlargement of the inclusion criteria. Deletion of some exclusion criteria. DSMB creation.
    02 Jul 2014
    Due to recruiting delay, opening of 2 new investigator sites (FR & UK).
    13 Oct 2014
    Addition of M18 visit.
    15 Jan 2015
    Due to non-clinical study results (effect teratogenic on rabbits) contraceptive measures have been added. Biotin & metabolites analysed at M12. Awareness of subjects regarding teratogenics' risks and laboratory interference.
    27 May 2015
    Extension of the study duration until end of EMA registration (i.e 36 months).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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