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    Clinical Trial Results:
    Oxcarbazepine as a neuroprotective agent in MS: phase 2a trial

    Summary
    EudraCT number
    		 2013-002419-87
    Trial protocol
    		 GB  
    Global end of trial date
    26 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jul 2019
    First version publication date
    03 Jul 2019
    Other versions
    Summary report(s)
    		 Adverse events information

    Trial information

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    Trial identification
    Sponsor protocol code
    008722
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02104661
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Queen Mary University of London
    Sponsor organisation address
    JMRO 5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    Mays Jawad, Barts Health NHS Trust, 0044 02078827260, research.governance@qmul.ac.uk
    Scientific contact
    Mays Jawad, Barts Health NHS Trust, 0044 02078827260, research.governance@qmul.ac.uk
    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
    12 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does oxcarbazepine protect people with multiple sclerosis (PwMS) from nerve loss? When we compare PwMS who take oxcarbazepine for one year to PwMS who take placebo, is the level of neurofilament light (NFL), a marker of nerve loss, in the CSF significantly reduced?
    Protection of trial subjects
    Cerebrospinal fluid (CSF) Neurofilament light chain (NFL) level measument require participants to undergo a Lumbar Puncture procedure Some people with multiple sclerosis (MS) will accept to have four lumbar punctures (LP) to measure NFL in order to have the chance of reducing the risk of permanent nerve loss. We have run a online pool asking people opinion about having LP in a trial for a neuroprotective drug in our site msres.org and had a positive outcome. We will have a youtube video showing what a LP with atraumatic needle is like for those who want to see it. Currently, the markers of neurodegeneration in the serum are not reliable or validated. The neuroprotective drug we are testing, oxcarbazepine, is a sodium channel blocker, a group of drugs that showed promise but not yet definite results in MS. It is also a widely used drug in Neurology, licensed for epilepsy. The dose we will use is lower than for epilepsy, which reduces the occurrence of dose dependent side effects. Adverse events side effects are monitored at every visit and safety bloods every three months. We will recruit people who are under licensed disease modifying drugs for MS, but who have raised levels of neurofilament in the CSF, a marker that there is continuous neurodegeneration. Even if we and the participants are blinded, it is possible to break the code in case of serious adverse events. Also, it is possible to unblind because of side effects and we have chosen not to have blinded independent assessors. The justification is that our primary outcome measures is objective and independent of the observer/analyst. Participants will be asked to give up to 60mls of blood for safety and tertiary research outcomes. Patients will asked to consent. A Data Safety Monitoring Committee will be put in place to independently monitor the safety of the patients and the ongoing values of the trial. The DSMC will meet after the first SAE or 1 month after 50% of participants have entered the Study
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 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
    United Kingdom: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants will be assessed for inclusion following informed consent. After their initial screening they will undergo a lumbar puncture for assessment of baseline Cerebrospinal fluid Neurofilament light (CSF NFL) levels. Only participants with raised CSF NFL levels (> 0.380ng/mL) will be eligible for randomization.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental: OxCarbazepine Treatment
    Arm description
    		 Treated for 48 weeks with OxCarbazepine 600mg (2 X 150mg tablets twice a day) alongside current DMDs
    Arm type
    		 Experimental

    Investigational medicinal product name
    OxCarbazepine Treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    300 mg twice a day

    Arm title
    		 Placebo Comparator: OxCarbazepine Placebo
    Arm description
    		 Treated for 48 weeks with OxCarbazepine Placebo (2 tablets twice a day) alongside current DMDs
    Arm type
    		 Placebo

    Investigational medicinal product name
    OxCarbazepine Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    tablets

    Number of subjects in period 1
    		Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo
    Started
    16
    14
    Completed
    15
    14
    Not completed
    1
    0
         Physician decision
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental: OxCarbazepine Treatment
    Reporting group description
    		 Treated for 48 weeks with OxCarbazepine 600mg (2 X 150mg tablets twice a day) alongside current DMDs

    Reporting group title
    Placebo Comparator: OxCarbazepine Placebo
    Reporting group description
    		 Treated for 48 weeks with OxCarbazepine Placebo (2 tablets twice a day) alongside current DMDs

    Reporting group values
    		 Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo Total
    Number of subjects
    		 16 14 30
    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)
    		 16 14 30
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.57 ( 9.61 ) 49.37 ( 6.18 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 5 16
        Male
    		 5 9 14

    End points

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    End points reporting groups
    Reporting group title
    Experimental: OxCarbazepine Treatment
    Reporting group description
    		 Treated for 48 weeks with OxCarbazepine 600mg (2 X 150mg tablets twice a day) alongside current DMDs

    Reporting group title
    Placebo Comparator: OxCarbazepine Placebo
    Reporting group description
    		 Treated for 48 weeks with OxCarbazepine Placebo (2 tablets twice a day) alongside current DMDs

    Primary: Primary: Mean cerebro-spinal fluid (CSF) neurofilament light chain (NFL) levels from baseline to 48 weeks between the active and placebo treated arms.

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    End point title
    		 Primary: Mean cerebro-spinal fluid (CSF) neurofilament light chain (NFL) levels from baseline to 48 weeks between the active and placebo treated arms.
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to 48 weeks
    End point values
    		 Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo
    Number of subjects analysed
    15
    14
    Units: pg / mL
        arithmetic mean (standard deviation)
    408.65 ( 125.94 )
    449.22 ( 164.88 )
    Statistical analysis title
    		 Primary Outcome: NFL CSF levels
    Statistical analysis description
    The primary analysis for this outcome will estimate the adjusted Active-Placebo difference in mean NFL at 48 weeks use the following simplified schematic for a multiple linear regression: NFL48w = Alpha + Beta.Active + Gamma1NFL baseline + Gamma2binaryEDSS baseline. Minimisation variables (both binary): Baseline CSF NFL level ( < 0.5ng/mL , > 0.5ng/mL ), Baseline Expanded Disability Status Scale (EDSS < 5.0 , > 5.0 )
    Comparison groups
    Experimental: OxCarbazepine Treatment v Placebo Comparator: OxCarbazepine Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.751
    Method
    		 ANCOVA
    Parameter type
    		 baseline adjusted mean difference
    Point estimate
    -15.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -112.46
         upper limit
    		 82.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    47.26

    Secondary: Secondary: Mean Expanded Disability Status Scale (EDSS) score from baseline to 48 weeks between the active and placebo treated arms

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    End point title
    		 Secondary: Mean Expanded Disability Status Scale (EDSS) score from baseline to 48 weeks between the active and placebo treated arms
    End point description
    End point type
    Secondary
    End point timeframe
    48 weeks from baseline
    End point values
    		 Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo
    Number of subjects analysed
    15
    14
    Units: score
        arithmetic mean (standard deviation)
    4.87 ( 1.16 )
    5.54 ( 1.01 )
    Statistical analysis title
    		 Secondary Outcome: EDSS
    Comparison groups
    Experimental: OxCarbazepine Treatment v Placebo Comparator: OxCarbazepine Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 ANCOVA
    Parameter type
    		 baseline adjusted mean difference
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13

    Secondary: Secondary: Mean "Twelve Item Multiple Sclerosis Walking Scale" (MSWS-12 v2) questionnaire score from baseline to 48 weeks between the active and placebo treated arms

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    End point title
    		 Secondary: Mean "Twelve Item Multiple Sclerosis Walking Scale" (MSWS-12 v2) questionnaire score from baseline to 48 weeks between the active and placebo treated arms
    End point description
    End point type
    Secondary
    End point timeframe
    48 weeks from baseline
    End point values
    		 Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo
    Number of subjects analysed
    15
    13
    Units: score
        arithmetic mean (standard deviation)
    52.70 ( 27.09 )
    73.44 ( 22.01 )
    Statistical analysis title
    		 Secondary Outcome: MSWS-12 v2
    Comparison groups
    Experimental: OxCarbazepine Treatment v Placebo Comparator: OxCarbazepine Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.042
    Method
    		 ANCOVA
    Parameter type
    		 baseline adjusted mean difference
    Point estimate
    -12.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.14
         upper limit
    		 -0.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.96

    Secondary: Secondary: Mean "Multiple Sclerosis Physical Impact Scale" (MSIS-29 v2) questionnaire score from baseline to 48 weeks between the active and placebo treated arms

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    End point title
    		 Secondary: Mean "Multiple Sclerosis Physical Impact Scale" (MSIS-29 v2) questionnaire score from baseline to 48 weeks between the active and placebo treated arms
    End point description
    End point type
    Secondary
    End point timeframe
    48 weeks from baseline
    End point values
    		 Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo
    Number of subjects analysed
    15
    14
    Units: score
        arithmetic mean (standard deviation)
    41.67 ( 21.46 )
    52.38 ( 18.43 )
    Statistical analysis title
    		 Secondary Outcome: MSIS-29 v2 Physical
    Comparison groups
    Experimental: OxCarbazepine Treatment v Placebo Comparator: OxCarbazepine Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.926
    Method
    		 ANCOVA
    Parameter type
    		 baseline adjusted mean difference
    Point estimate
    -0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.82
         upper limit
    		 9.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    5

    Secondary: Secondary: Mean "Multiple Sclerosis Psychological Impact Scale" (MSIS-29 v2) questionnaire score from baseline to 48 weeks between the active and placebo treated arms

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    End point title
    		 Secondary: Mean "Multiple Sclerosis Psychological Impact Scale" (MSIS-29 v2) questionnaire score from baseline to 48 weeks between the active and placebo treated arms
    End point description
    End point type
    Secondary
    End point timeframe
    48 weeks from baseline
    End point values
    		 Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo
    Number of subjects analysed
    15
    14
    Units: score
        arithmetic mean (standard deviation)
    36.54 ( 21.54 )
    35.19 ( 17.30 )
    Statistical analysis title
    		 Secondary Outcome: MSIS-29 v2 Psychological
    Comparison groups
    Placebo Comparator: OxCarbazepine Placebo v Experimental: OxCarbazepine Treatment
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.692
    Method
    		 ANCOVA
    Parameter type
    		 baseline adjusted mean difference
    Point estimate
    2.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.46
         upper limit
    		 14.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.67

    Secondary: Secondary: Mean Fatigue score from baseline to 48 weeks between the active and placebo treated arms

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    End point title
    		 Secondary: Mean Fatigue score from baseline to 48 weeks between the active and placebo treated arms
    End point description
    End point type
    Secondary
    End point timeframe
    48 weeks from baseline
    End point values
    		 Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo
    Number of subjects analysed
    15
    13
    Units: score
        arithmetic mean (standard deviation)
    54.80 ( 22.40 )
    63.93 ( 13.06 )
    Statistical analysis title
    		 Secondary Outcome: Fatigue score
    Comparison groups
    Experimental: OxCarbazepine Treatment v Placebo Comparator: OxCarbazepine Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.849
    Method
    		 ANCOVA
    Parameter type
    		 baseline adjusted mean difference
    Point estimate
    -1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.01
         upper limit
    		 13.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.07

    Secondary: Secondary: Mean Pain score from baseline to 48 weeks between the active and placebo treated arms

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    End point title
    		 Secondary: Mean Pain score from baseline to 48 weeks between the active and placebo treated arms
    End point description
    End point type
    Secondary
    End point timeframe
    48 weeks from baseline
    End point values
    		 Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo
    Number of subjects analysed
    15
    14
    Units: score
        arithmetic mean (standard deviation)
    26.01 ( 25.75 )
    35.52 ( 29.91 )
    Statistical analysis title
    		 Secondary Outcome: Pain score
    Comparison groups
    Experimental: OxCarbazepine Treatment v Placebo Comparator: OxCarbazepine Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.229
    Method
    		 ANCOVA
    Parameter type
    		 baseline adjusted mean difference
    Point estimate
    -12.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.47
         upper limit
    		 8.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.85

    Secondary: Secondary: Mean Symbol Digit Modalities Test (SDMT) score from baseline to 48 weeks between the active and placebo treated arms

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    End point title
    		 Secondary: Mean Symbol Digit Modalities Test (SDMT) score from baseline to 48 weeks between the active and placebo treated arms
    End point description
    End point type
    Secondary
    End point timeframe
    48 weeks from baseline
    End point values
    		 Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo
    Number of subjects analysed
    15
    14
    Units: score
        arithmetic mean (standard deviation)
    42.67 ( 19.82 )
    42.07 ( 11.03 )
    Statistical analysis title
    		 Secondary Outcome: SDMT
    Comparison groups
    Experimental: OxCarbazepine Treatment v Placebo Comparator: OxCarbazepine Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.838
    Method
    		 ANCOVA
    Parameter type
    		 baseline adjusted mean difference
    Point estimate
    -0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.83
         upper limit
    		 4.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.57

    Secondary: Secondary: Mean Sloan Chart score from baseline to 48 weeks between the active and placebo treated arms

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    End point title
    		 Secondary: Mean Sloan Chart score from baseline to 48 weeks between the active and placebo treated arms
    End point description
    End point type
    Secondary
    End point timeframe
    48 weeks from baseline
    End point values
    		 Experimental: OxCarbazepine Treatment Placebo Comparator: OxCarbazepine Placebo
    Number of subjects analysed
    14
    12
    Units: score
        arithmetic mean (standard deviation)
    8.41 ( 5.85 )
    16.53 ( 20.99 )
    Statistical analysis title
    		 Secondary Outcome: Sloan Chart
    Comparison groups
    Experimental: OxCarbazepine Treatment v Placebo Comparator: OxCarbazepine Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.142
    Method
    		 ANCOVA
    Parameter type
    		 baseline adjusted mean difference
    Point estimate
    -9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.51
         upper limit
    		 3.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.71

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    between baseline and 48 weeks
    Adverse event reporting additional description
    Adverse events were recorded for all subjects randomised
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Experimental: OxCarbazepine Treatment
    Reporting group description
    		 Treated for 48 weeks with OxCarbazepine 600mg (2 X 150mg tablets twice a day) alongside current DMDs

    Reporting group title
    Placebo comparator - OxCarbazepine Placebo
    Reporting group description
    		 Treated for 48 weeks with OxCarbazepine Placebo (2 tablets twice a day) alongside current DMDs

    Serious adverse events
    		 Experimental: OxCarbazepine Treatment Placebo comparator - OxCarbazepine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Experimental: OxCarbazepine Treatment Placebo comparator - OxCarbazepine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The system has an error ( see EMA call ref: SD-277614) that does not allow us to add the non serious adverse events. We have added a document detailing the adverse events for this trial.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Oct 2015
    The purpose of this substantial amendment is to make administrative changes, clarifications and corrections. The sections which have been reviewed include the inclusion/exclusion criteria, the criteria for premature withdrawal and the prohibited concomitant medications. Summary of revisions: 1 The study title in the study summary and the first protocol page have been made consistent. 2. The unit used for cerebral spinal fluid neurofilament (CSF NFL) has been corrected from pg/mL to ng/mL. 3. Numbering has been introduced to replace bullet points in sections 3.3 and 3.4. 4. Protocol section 3.3: in inclusion criterion 3 the CSF NFL threshold for eligibility has been lowered from 0.690 ng/mL to 0.380 ng/mL. The rationale for this is detailed in Section 1.1 ‘Background’. It was observed on the screened participants that the values of CSF NFL in people with early SPMS who are on effective disease-modifying therapies are lower than the published results; this has only come to light since starting this study and will increase the number of subjects eligible for the study. 6. Protocol section 4.8: Use of induction therapies as a DMD for MS has been clarified. 7. Two new exclusion criteria have been introduced: Exclusion criterion 2 to exclude participants with a diagnosis of primary progressive or progressive relapsing MS to be consistent with the study summary and exclusion criterion 11 to exclude participants who have received OxCbz or Cbz in the previous 12 weeks from baseline. 8. The use of sodium or calcium channel blockers has been removed from sections 3.3 ‘Exclusion criteria’, 4.8 ‘Prior and concomitant medications’ and 4.10 ‘Medications to control MS symptoms’. This has been removed because sodium and calcium channel blockers do not interfere with the mechanism of Oxcarbazepine. The use of induction DMDs has been clarified in section 4.8. 9 DMD discontinuation has been introduced as an additional criteria for premature withdrawal in section 3.4 to be c
    21 Oct 2016
    The purpose of this substantial amendment is to make administrative changes, clarifications and corrections. Various protocol sections were reviewed, including: Study summary, Study design, Study population, Inclusion/Exclusion Criteria, Investigational Medicinal Product, Schedule of assessments table, Statistical considerations and Data handling and record keeping. Summary of revisions: 1. Exclusion criteria 1 has been updated to include details of adequate methods of contraception and to clarify the requirements for participants in same sex relationships and those who are not sexually active. 2. Exclusion criteria 3 has been updated to clarify the use of pulse intravenous or oral steroids for MS relapses 3. Inclusion criterion 2 in Protocol Section 3.3 has been updated to allow for the temporary interruption of disease modifying drug at the discretion of the Investigator. For consistency, this change was also applied to criterion for premature withdrawal n.8 in section 3.4 and to section 4.8 ‘Prior and concomitant medications’. 4. The number of participants required to be randomised in the study has been reduced to 30 (15 per arm). The number of participants required to complete the study has been reduced to 26. This decision is substantiated by a review of the power calculation for the study by the study statistician and CI. The data collected from the baseline sample was used to assess that the sample size could safely be reduced. 5. The level of CSF NFL level reduction for the detection of a significant treatment effect has been updated to 30%. 6. The use of the Simplified Investigational Medicinal Product Dossier in the study has been clarified. References to the SIMPD have been made consistent throughout all protocol sections. 5. Administrative corrections were made to the IMP section 6. The information included in the separate sections of the IMP label has been clarified. 7. To follow is a list of the changes made

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The system has an error ( see EMA call ref: SD-277614) that does not allow us to add the non serious adverse events. We have added a document detailing the adverse events for this trial.
    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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