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    Clinical Trial Results:
    MD1003 IN ADRENOMYELONEUROPATHY: A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY

    Summary
    EudraCT number
    		 2014-000698-38
    Trial protocol
    		 ES  
    Global end of trial date
    23 Jun 2017

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MD1003CT2014-01AMN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedDay Pharmaceuticals
    Sponsor organisation address
    24-26 Rue de la Pépinière, Paris, France, 75008
    Public contact
    Service of Neurology - Bicêtre Hospital, Prof Patrick Aubourg, frederic.sedel@medday-pharma.com
    Scientific contact
    Service of Neurology - Bicêtre Hospital, Prof Patrick Aubourg, 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
    16 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the superiority of MD1003 (biotin) at 300 mg/day over placebo in the clinical improvement of patients with Adrenomyeloneuropathy
    Protection of trial subjects
    The safety of MD1003 was assessed by recording of adverse events (AEs), clinical examinations (vital signs, ECG), and standard maboratory testing (hematology, biochemistry).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Oct 2014
    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
    Spain: 13
    Country: Number of subjects enrolled
    France: 30
    Country: Number of subjects enrolled
    Germany: 24
    Worldwide total number of subjects
    67
    EEA total number of subjects
    67
    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)
    67
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited to the study in 4 sites: In France: 2 sites - 30 subjects In Germany: 1 site - 24 subjects In Spain: 1 site - 13 subjects The study was conducted between 28 October 2014 and 23 June 2017.

    Pre-assignment
    Screening details
    		 A total of 71 subjetcs were screened and 67 subjects were randomized, 23 subjects in the Placebo group and 44 subjects in the MD1003 group.

    Period 1
    Period 1 title
    Overall trial (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
    Blinding implementation details
    The double blinding was protected by sealed envelopes that were stored in the pharmacy and the Investigator's office.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MD1003
    Arm description
    		 During the first 12-month double-blind placebo-controlled period, 44 subjects recieved 300 mg/day of MD1003. During the 12-month extension phase, all subjects recieved MD1003 300 mg/day.
    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
    MD1003 consists 100 mg biotin and excipients (lactose, magnesium stearate, croscarmellose sodium, silica). MD1003 was taken orally and swallowed with a glass of water, with or without food, three times a day for a total of 300 mg/day.

    Arm title
    		 Placebo
    Arm description
    		 During the first 12-month double-blind placebo-controlled period, 23 recieved 300 mg/day of Placebo. During the 12-month extension phase, all subjects recieved MD1003 300 mg/day.
    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
    Placebo was administered as a capsule consisting of 100 mg lactose powder and other excipients (magnesium stearate, croscarmellose sodium, silica). Placebo was taken orally and swallowed with a glass of water, with or without food, three times a day for a total of 300 mg/day.

    Number of subjects in period 1
    		MD1003 Placebo
    Started
    44
    23
    Completed
    43
    23
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 67 67
    Age categorical
    The study was conducted only on male subjects.
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.6 ( 8.46 ) -
    Gender categorical
    Units: Subjects
        Male
    		 67 67
    Subject analysis sets

    Subject analysis set title
    Subjects under MD1003
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The subjects in the MD1003 group took 300 mg/day of MD1003 during 12 months (100mg tid).

    Subject analysis set title
    Subjects under Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The subjects in the Placebo group took 300 mg/day of placebo during 12 months (100mg tid).

    Subject analysis sets values
    		 Subjects under MD1003 Subjects under Placebo
    Number of subjects
    44
    23
    Age categorical
    The study was conducted only on male subjects.
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.2 ( 8.80 )
    43.4 ( 7.89 )
    Gender categorical
    Units: Subjects
        Male
    44
    23

    End points

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    End points reporting groups
    Reporting group title
    MD1003
    Reporting group description
    		 During the first 12-month double-blind placebo-controlled period, 44 subjects recieved 300 mg/day of MD1003. During the 12-month extension phase, all subjects recieved MD1003 300 mg/day.

    Reporting group title
    Placebo
    Reporting group description
    		 During the first 12-month double-blind placebo-controlled period, 23 recieved 300 mg/day of Placebo. During the 12-month extension phase, all subjects recieved MD1003 300 mg/day.

    Subject analysis set title
    Subjects under MD1003
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The subjects in the MD1003 group took 300 mg/day of MD1003 during 12 months (100mg tid).

    Subject analysis set title
    Subjects under Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The subjects in the Placebo group took 300 mg/day of placebo during 12 months (100mg tid).

    Primary: The mean change of 2-minute walking test (2MWT) between baseline and Month 12

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    End point title
    		 The mean change of 2-minute walking test (2MWT) between baseline and Month 12
    End point description
    End point type
    Primary
    End point timeframe
    12 months: from baseline to month 12
    End point values
    		 Subjects under MD1003 Subjects under Placebo
    Number of subjects analysed
    44
    23
    Units: meter
        arithmetic mean (standard deviation)
    -1.25 ( 15.36 )
    2.27 ( 22.99 )
    Statistical analysis title
    		 Change from baseline
    Comparison groups
    Subjects under MD1003 v Subjects under Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2714
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.44
         upper limit
    		 3.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.33

    Secondary: Proportion of subjects with improved 2MWT at least 20% at M9 and M12

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    End point title
    		 Proportion of subjects with improved 2MWT at least 20% at M9 and M12
    End point description
    End point type
    Secondary
    End point timeframe
    12 months (during double blind phase)
    End point values
    		 Subjects under MD1003 Subjects under Placebo
    Number of subjects analysed
    44
    23
    Units: meter
        number (confidence interval 100%)
    1 (0.0342 to 7.9793)
    1 (0.0342 to 7.9793)
    No statistical analyses for this end point

    Secondary: Proportion of subjects with improved TW25 of at least 20% at M9 and M12

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    End point title
    		 Proportion of subjects with improved TW25 of at least 20% at M9 and M12
    End point description
    End point type
    Secondary
    End point timeframe
    M9 and M12
    End point values
    		 Subjects under MD1003 Subjects under Placebo
    Number of subjects analysed
    44
    23
    Units: second
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Mean change in TW25 between baseline and M12

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    End point title
    		 Mean change in TW25 between baseline and M12
    End point description
    End point type
    Secondary
    End point timeframe
    During double-blind period (12 months)
    End point values
    		 Subjects under MD1003 Subjects under Placebo
    Number of subjects analysed
    Units: second
        arithmetic mean (confidence interval 95%)
    0.62 (0.14 to 1.10)
    0.84 (0.23 to 1.45)
    No statistical analyses for this end point

    Secondary: Mean change in TUG between baseline and M12

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    End point title
    		 Mean change in TUG between baseline and M12
    End point description
    End point type
    Secondary
    End point timeframe
    12 months (from baseline to M12)
    End point values
    		 Subjects under MD1003 Subjects under Placebo
    Number of subjects analysed
    44
    23
    Units: second
        arithmetic mean (standard deviation)
    0.53 ( 2.42 )
    -0.60 ( 3.41 )
    No statistical analyses for this end point

    Secondary: Mean change in the EQ-5D between baseline and M12

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    End point title
    		 Mean change in the EQ-5D between baseline and M12
    End point description
    End point type
    Secondary
    End point timeframe
    Between M0 and M12 of the study period.
    End point values
    		 Subjects under MD1003 Subjects under Placebo
    Number of subjects analysed
    44
    23
    Units: EQ VAS
        arithmetic mean (standard deviation)
    -4.23 ( 11.32 )
    -4.32 ( 15.22 )
    No statistical analyses for this end point

    Secondary: Mean change in the Qualiveen between baseline and M12

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    End point title
    		 Mean change in the Qualiveen between baseline and M12
    End point description
    End point type
    Secondary
    End point timeframe
    From M0 to M12 of the study period.
    End point values
    		 Subjects under MD1003 Subjects under Placebo
    Number of subjects analysed
    44
    23
    Units: Qualiveen score
        arithmetic mean (standard deviation)
    0.09 ( 0.69 )
    0.27 ( 0.59 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 months (the whole study)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    MD1003/MD1003
    Reporting group description
    		 Subjects recieved MD1003 during the whole study (12 months double-blind period and 12 months open label)

    Reporting group title
    Placebo/MD1003
    Reporting group description
    		 Subjects recieved placebo during double-blind phase (12 months) and MD1003 during open label phase (12 months).

    Serious adverse events
    		 MD1003/MD1003 Placebo/MD1003
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 44 (15.91%)
    9 / 23 (39.13%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Coronary angioplasty
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder operation
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardinal infarction
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy of partner
         subjects affected / exposed
    1 / 44 (2.27%)
    2 / 23 (8.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    4 / 44 (9.09%)
    3 / 23 (13.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroid mass
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pathological fracture
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MD1003/MD1003 Placebo/MD1003
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 44 (84.09%)
    20 / 23 (86.96%)
    Vascular disorders
    Contusion
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Catheter placement
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Coronary angioplasty
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Glaucoma surgery
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Shoulder operation
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Wisdom teeth removal
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    13 / 44 (29.55%)
    10 / 23 (43.48%)
         occurrences all number
    18
    14
    Fatigue
         subjects affected / exposed
    1 / 44 (2.27%)
    3 / 23 (13.04%)
         occurrences all number
    1
    3
    Asthenia
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Cyst
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hernia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Prostatitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Sleep apnoea syndrome
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    3
    Depression
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Anxiety
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Investigations
    Laboratory test interference
         subjects affected / exposed
    8 / 44 (18.18%)
    0 / 23 (0.00%)
         occurrences all number
    8
    0
    Carotid bruit
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Weight increased
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Exposure via father
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Ankle fracture
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Foot fracture
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Hand fracture
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Thermal burn
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Upper limb fracture
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Vascular graft occlusion
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Wrist fracture
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 44 (9.09%)
    1 / 23 (4.35%)
         occurrences all number
    5
    1
    Somnolence
         subjects affected / exposed
    2 / 44 (4.55%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Sciatica
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 23 (4.35%)
         occurrences all number
    1
    2
    Burning sensation
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Epilepsy
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Rib fracture
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Dry eye
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Keratitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Visual acuity reduced
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Vertigo positional
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 44 (2.27%)
    3 / 23 (13.04%)
         occurrences all number
    1
    4
    Constipation
         subjects affected / exposed
    2 / 44 (4.55%)
    2 / 23 (8.70%)
         occurrences all number
    2
    2
    Gastritis
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Anal incontinence
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 44 (4.55%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Alopecia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Enuresis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Micturition urgency
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Pollakiuria
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Thyroid mass
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hypersensitivity
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 44 (11.36%)
    4 / 23 (17.39%)
         occurrences all number
    5
    4
    Arthralgia
         subjects affected / exposed
    5 / 44 (11.36%)
    5 / 23 (21.74%)
         occurrences all number
    5
    5
    Musculoskeletal pain
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 23 (0.00%)
         occurrences all number
    4
    0
    Bursitis
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Joint swelling
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Torticollis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Muscle twitching
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Muscular weakness
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Osteoporosis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Pathological fracture
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 44 (6.82%)
    3 / 23 (13.04%)
         occurrences all number
    5
    3
    urinary tract infection
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 23 (8.70%)
         occurrences all number
    6
    3
    Gastroenteritis
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 23 (8.70%)
         occurrences all number
    4
    2
    Sinusitis
         subjects affected / exposed
    2 / 44 (4.55%)
    2 / 23 (8.70%)
         occurrences all number
    2
    4
    Nasopharyngitis
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 23 (0.00%)
         occurrences all number
    4
    0
    Bronchitis
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Pharyngitis
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 23 (4.35%)
         occurrences all number
    1
    2
    Influenza
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Gastrointestinal infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Pilonidal cyst
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Soft tissue infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Urosepsis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2014
    This protocol amendment is only for Spain site. Potential risks on the use of biotin with peptic ulcer and recurrent gastiritis, and skin rash and fever are updated.
    21 Jan 2015
    This protocol amendment is only for German site. MOS SF36 quality of life questionnaire from the secondary endpoints evaluation criteria is removed.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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