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    Clinical Trial Results:
    Treatment of Optic Neuritis with Erythropoietin: a randomised, double-blind, placebo-controlled trial

    Summary
    EudraCT number
    		 2013-002515-10
    Trial protocol
    		 DE  
    Global end of trial date
    26 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2020
    First version publication date
    16 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P000053
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01962571
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS: DRKS00005298
    Sponsors
    Sponsor organisation name
    Medical Center - University of Freiburg
    Sponsor organisation address
    Breisacher Str. 153, Freiburg, Germany, 79110
    Public contact
    Prof. Dr. Wolf A. Lagrèze, Medical Center - University of Freiburg, +49 76127040100, wolf.lagreze@uniklinik-freiburg.de
    Scientific contact
    Prof. Dr. Wolf A. Lagrèze, Medical Center - University of Freiburg, +49 76127040100, wolf.lagreze@uniklinik-freiburg.de
    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
    26 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determination of the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone (standard of care) as assessed by measurements of global retinal nerve fibre layer thickness (RNFLT-G) and low contrast visual acuity (LCVA) 6 months after randomisation
    Protection of trial subjects
    An independent Data Monitoring Committee (DMC) was established. The DMC consisted of two physicians and one statistician. The function of the DMC was to monitor the course of the study and if necessary to give a recommendation to the steering committee for discontinuation, modification or continuation of the study. The underlying principles for the DMC were ethical and safety aspects for the patients. It was the task of the DMC to examine whether the conduct of the study was still ethically justifiable, whether security of the patients was ensured, and whether the process of the study is acceptable. For this purpose, the DMC had to be informed about the adherence to the protocol, the patient recruitment, the observed serious adverse events, and deaths. Serious adverse events were reported to the DMC at regular intervals.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 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
    Germany: 103
    Worldwide total number of subjects
    103
    EEA total number of subjects
    103
    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)
    103
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 108 patients were enrolled and randomized. 53 patients were randomized to placebo and 55 to EPO. In the EPO group, one patient was a screen failure. In each group one patient was lost to follow-up with no post baseline OCT reading. In the placebo group, one patient withdrew informed consent and one violated diagnosis inclusion criterion.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Epoetin alfa
    Arm description
    		 Eopeotin alfa HEXAL (R) 40,000 IU/1 ml solution for injection in a pre-filled syringe
    Arm type
    		 Experimental

    Investigational medicinal product name
    Epoetin alfa
    Investigational medicinal product code
    Other name
    Epoetin alfa HEXAL® 40,000 IU/1 ml solution for injection in a pre-filled syringe
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose: 33,000 IU (approx. 0.85 ml) administered on days 1, 2 and 3 immediately after methylprednisolone.

    Arm title
    		 Sodium chloride
    Arm description
    		 0.85 ml isotone sodium chloride solution (0.9%) solution for injection, 1x daily, 3 consecutive days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium choride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.9% saline solution i.v., 1x daily, 3 consecutive days. Dose: 0.85 ml

    Number of subjects in period 1
    		Epoetin alfa Sodium chloride
    Started
    52
    51
    Completed
    52
    51

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Epoetin alfa
    Reporting group description
    		 Eopeotin alfa HEXAL (R) 40,000 IU/1 ml solution for injection in a pre-filled syringe

    Reporting group title
    Sodium chloride
    Reporting group description
    		 0.85 ml isotone sodium chloride solution (0.9%) solution for injection, 1x daily, 3 consecutive days

    Reporting group values
    		 Epoetin alfa Sodium chloride Total
    Number of subjects
    		 52 51 103
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 52 51 103
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 38 33 71
        Male
    		 14 18 32

    End points

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    End points reporting groups
    Reporting group title
    Epoetin alfa
    Reporting group description
    		 Eopeotin alfa HEXAL (R) 40,000 IU/1 ml solution for injection in a pre-filled syringe

    Reporting group title
    Sodium chloride
    Reporting group description
    		 0.85 ml isotone sodium chloride solution (0.9%) solution for injection, 1x daily, 3 consecutive days

    Primary: Retinal fiber layer thickness (RNFLT-G-12) 3.5

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    End point title
    		 Retinal fiber layer thickness (RNFLT-G-12) 3.5
    End point description
    Global RNFL Thickness 3.5 [μm] fellow eye at baseline minus affected eye at Week 26 - Population FAS
    End point type
    Primary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    46
    Units: micrometer (µm)
        arithmetic mean (standard deviation)
    15.93 ( 14.91 )
    14.65 ( 15.60 )
    Statistical analysis title
    		 Adjusted difference
    Comparison groups
    Sodium chloride v Epoetin alfa
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted difference
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.51
         upper limit
    		 7.55

    Primary: Low contrast visual acuity (LCVA)

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    End point title
    		 Low contrast visual acuity (LCVA)
    End point description
    Low contrast visual acuity (2.5% Sloan chart score) at Week 26 - study eye - Population FAS
    End point type
    Primary
    End point timeframe
    26 weeks after randomization
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    49
    Units: Sloan chart score
        arithmetic mean (standard deviation)
    49.60 ( 21.31 )
    49.06 ( 21.93 )
    Statistical analysis title
    		 Adjusted difference
    Comparison groups
    Epoetin alfa v Sodium chloride
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted difference
    Point estimate
    -4.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.06
         upper limit
    		 5.01

    Secondary: RNFLT-PMB-12

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    End point title
    		 RNFLT-PMB-12
    End point description
    PMB RNFL Thickness 3.5 [μm] fellow eye at baseline minus affected eye at Week 26 - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    45
    Units: micrometer (µm)
        arithmetic mean (standard deviation)
    12.38 ( 12.51 )
    11.96 ( 12.76 )
    No statistical analyses for this end point

    Secondary: RNFLT temporal (RNFLT-T-12)

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    End point title
    		 RNFLT temporal (RNFLT-T-12)
    End point description
    Temporal RNFL Thickness 3.5 [μm] fellow eye at baseline minus affected eye at Week 26 - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    46
    Units: micrometer (µm)
        arithmetic mean (standard deviation)
    17.64 ( 16.89 )
    17.98 ( 14.81 )
    No statistical analyses for this end point

    Secondary: Total macular volume (TMV)

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    End point title
    		 Total macular volume (TMV)
    End point description
    RNFL volume (ETDRS) [mm³] fellow eye at baseline minus affected eye at Week 26 - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    41
    42
    Units: cubic millimeters
        arithmetic mean (standard deviation)
    0.19 ( 0.13 )
    0.14 ( 0.17 )
    No statistical analyses for this end point

    Secondary: Global RNFL Thickness 3.5 [μm]

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    End point title
    		 Global RNFL Thickness 3.5 [μm]
    End point description
    Global RNFL Thickness 3.5 [μm] - study eye - Population FAS
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    48
    Units: micrometer (µm)
        arithmetic mean (standard deviation)
    85.7 ( 18.1 )
    84.7 ( 18.0 )
    No statistical analyses for this end point

    Secondary: Temporal RNFL Thickness 3.5 [μm]

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    End point title
    		 Temporal RNFL Thickness 3.5 [μm]
    End point description
    Temporal RNFL Thickness 3.5 [μm] - study eye - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    48
    Units: micrometer (µm)
        arithmetic mean (standard deviation)
    52.4 ( 16.6 )
    53.8 ( 18.9 )
    No statistical analyses for this end point

    Secondary: Temporal superior RNFL Thickness 3.5 [μm]

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    End point title
    		 Temporal superior RNFL Thickness 3.5 [μm]
    End point description
    Temporal superior RNFL Thickness 3.5 [μm] - study eye - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    48
    Units: micrometer (µm)
        arithmetic mean (standard deviation)
    113.4 ( 31.0 )
    113.9 ( 34.0 )
    No statistical analyses for this end point

    Secondary: PMB RNFL Thickness 3.5 [μm]

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    End point title
    		 PMB RNFL Thickness 3.5 [μm]
    End point description
    PMB RNFL Thickness 3.5 [μm] - study eye - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    46
    Units: micrometer (µm)
        arithmetic mean (standard deviation)
    39.7 ( 11.8 )
    40.2 ( 12.8 )
    No statistical analyses for this end point

    Secondary: Total macular volume (TMV)

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    End point title
    		 Total macular volume (TMV)
    End point description
    Total macular volume (TMV) [mm³] - study eye - at week 26 - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    39
    41
    Units: cubic millimeters
        arithmetic mean (standard deviation)
    8.43 ( 0.43 )
    7.99 ( 1.31 )
    No statistical analyses for this end point

    Secondary: Quality of life

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    End point title
    		 Quality of life
    End point description
    NEI VQF25 summary score at Week 26
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    39
    46
    Units: NEI VQF25 summary score
        arithmetic mean (standard deviation)
    90.7 ( 11.8 )
    89.0 ( 11.7 )
    No statistical analyses for this end point

    Secondary: Quality of life - change from baseline

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    End point title
    		 Quality of life - change from baseline
    End point description
    NEI VQF25 summary score - change from baseline to Week 26
    End point type
    Secondary
    End point timeframe
    change from baseline to Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    38
    45
    Units: NEI VQF25 summary score
        arithmetic mean (standard error)
    16.4 ( 14.6 )
    23.7 ( 13.7 )
    No statistical analyses for this end point

    Secondary: EDSS

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    End point title
    		 EDSS
    End point description
    Expanded Disability Status Scale (EDSS) score
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    47
    Units: EDSS score
        arithmetic mean (standard deviation)
    0.37 ( 0.77 )
    0.72 ( 0.86 )
    No statistical analyses for this end point

    Secondary: VEP latency - fellow eye

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    End point title
    		 VEP latency - fellow eye
    End point description
    VEP latency at Week 26: Fellow eye - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    48
    Units: msec
        arithmetic mean (standard deviation)
    105.38 ( 12.88 )
    106.06 ( 12.36 )
    No statistical analyses for this end point

    Secondary: VEP latency - study eye

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    End point title
    		 VEP latency - study eye
    End point description
    VEP latency at Week 26: Study eye - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    48
    Units: msec
        arithmetic mean (standard deviation)
    120.99 ( 20.42 )
    118.72 ( 20.13 )
    No statistical analyses for this end point

    Secondary: VEP amplitude - fellow eye

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    End point title
    		 VEP amplitude - fellow eye
    End point description
    VEP amplitude at Week 26: Fellow eye - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    46
    Units: µV
        arithmetic mean (standard deviation)
    11.94 ( 5.64 )
    10.73 ( 5.45 )
    No statistical analyses for this end point

    Secondary: VEP amplitude - study eye

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    End point title
    		 VEP amplitude - study eye
    End point description
    VEP amplitude at Week 26: Study eye - Population FAS
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Epoetin alfa Sodium chloride
    Number of subjects analysed
    42
    46
    Units: µV
        arithmetic mean (standard deviation)
    9.52 ( 5.02 )
    8.84 ( 5.35 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Complete study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Epoetin alfa
    Reporting group description
    		 Epoetin alfa: Eopeotin alfa HEXAL (R) 40,000 IU/1 ml solution for injection in a pre-filled syringe

    Reporting group title
    Placebo
    Reporting group description
    		 Sodium chloride (Placebo): 0.85 ml isotone sodium chloride solution (0.9%) solution for injection, 1x daily, 3 consecutive days

    Serious adverse events
    		 Epoetin alfa Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 53 (15.09%)
    4 / 52 (7.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Nasal sinus cancer
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post lumbar puncture syndrome
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Anal fistula excision
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (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
    Transverse sinus thrombosis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Visual acuity reduced
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Epoetin alfa Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 53 (79.25%)
    42 / 52 (80.77%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pleomorphic adenoma
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 53 (0.00%)
    4 / 52 (7.69%)
         occurrences all number
    0
    5
    Hypertension
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    2
    Peripheral coldness
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Thrombophlebitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Removal of foreign body from eye
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Tonsillectomy
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Tumour excision
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site erosion
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    7 / 53 (13.21%)
    5 / 52 (9.62%)
         occurrences all number
    7
    5
    General physical health deterioration
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Hunger
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 52 (5.77%)
         occurrences all number
    2
    3
    Malaise
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    3
    Panic attack
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood potassium increased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Nuclear magnetic resonance imaging abnormal
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Post lumbar puncture syndrome
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 52 (1.92%)
         occurrences all number
    3
    1
    Cardiac disorders
    Cardiovascular disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 52 (3.85%)
         occurrences all number
    3
    2
    Headache
         subjects affected / exposed
    15 / 53 (28.30%)
    13 / 52 (25.00%)
         occurrences all number
    26
    17
    Hemianaesthesia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    2
    Paraesthesia
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 52 (0.00%)
         occurrences all number
    3
    0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Detachment of retinal pigment epithelium
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Diplopia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Eye pain
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 52 (3.85%)
         occurrences all number
    1
    2
    Keratitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Ocular discomfort
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Photophobia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Visual acuity reduced
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 52 (3.85%)
         occurrences all number
    2
    2
    Visual impairment
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    3 / 53 (5.66%)
    3 / 52 (5.77%)
         occurrences all number
    3
    3
    Dyspepsia
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Gastric disorder
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    6 / 53 (11.32%)
    3 / 52 (5.77%)
         occurrences all number
    6
    3
    Toothache
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 52 (1.92%)
         occurrences all number
    1
    1
    Hepatobiliary disorders
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Drug eruption
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 52 (3.85%)
         occurrences all number
    2
    2
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 52 (1.92%)
         occurrences all number
    2
    1
    Back pain
         subjects affected / exposed
    5 / 53 (9.43%)
    4 / 52 (7.69%)
         occurrences all number
    5
    4
    Groin pain
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Muscular weakness
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 52 (3.85%)
         occurrences all number
    1
    2
    Neck pain
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    2
    Pain in extremity
         subjects affected / exposed
    4 / 53 (7.55%)
    0 / 52 (0.00%)
         occurrences all number
    4
    0
    Spinal pain
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 52 (1.92%)
         occurrences all number
    1
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 52 (1.92%)
         occurrences all number
    1
    1
    Cystitis
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 52 (3.85%)
         occurrences all number
    1
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 52 (3.85%)
         occurrences all number
    1
    2
    Gastroenteritis viral
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Laryngitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Lyme disease
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    11 / 53 (20.75%)
    9 / 52 (17.31%)
         occurrences all number
    15
    12
    Otitis media
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 52 (1.92%)
         occurrences all number
    3
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 52 (3.85%)
         occurrences all number
    1
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 52 (1.92%)
         occurrences all number
    1
    1
    Vitamin D deficiency
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26932144
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    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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