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    Clinical Trial Results:
    A 48-week, double-blind, randomized, multi-center, parallelgroup study comparing structural changes in the retina and evolution of visual function after immediate versus delayed treatment with fingolimod in patients with acute demyelinating optic neuritis

    Summary
    EudraCT number
    		 2012-002968-27
    Trial protocol
    		 ES   IT   GB   DE  
    Global end of trial date
    07 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    29 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CFTY720D2402
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01757691
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111 ,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111 ,
    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
    07 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess if fingolimod will reduce the mean retinal nerve fiber layer (RNFL) thinning (measured as the OCT-determined difference between the RNFLT of the affected eye after 18 weeks of treatment and the baseline RNFLT of the fellow eye) relative to placebo in patients with suspected ADON, all of whom will receive standard steroid treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial. Patients suffering from a MS relapse during the study and agreeing to continue the study after formal re-consenting were to be treated with a standard course of intravenous corticosteroids (methylprednisolone) on an in-patient or out-patient basis as clinically warranted. Intravenous steroid treatment for a relapse should have consisted of 3 to 5 days and up to 1000 mg methylprednisolone daily. Use of any oral tapering was not permitted. Standard-of-care procedures were to be followed during treatment of relapses as well as the instructions in the protocol for the conduct of the study MRI during relapse and steroid treatment. Investigators were to have considered the added immunosuppressive effects of corticosteroid therapy and increased vigilance regarding infections during such treatment and in the weeks following administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Aug 2013
    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: 1
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    2
    EEA total number of subjects
    1
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was terminated due to low patient enrollment.

    Pre-assignment
    Screening details
    		 There was a screening period of -1 to - 14 Days during which patient was treated with standard steroid therapy. Approximately 126 were planned to be enrolled.

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

    Arms
    Arm title
    		 Fingolimod 0.5mg/Daily
    Arm description
    		 Oral capsule dose was given once daily for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fingolimod
    Investigational medicinal product code
    FTY720
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The study medication (fingolimod 0.5 mg or placebo) was dispensed at the randomization visit after patient eligibility was confirmed and at each visit. The patient was instructed to take 1 capsule of study medication once daily by mouth, preferably at the same time every day, with or without food. At the Week 18 visit, patients in the placebo treatment arm were switched over to fingolimod 0.5 mg once daily. The study treatment arm continued to be blinded to the site and patient. Detailed guidelines for monitoring of patients taking their first dose of study drug and management of bradycardia were outlined in the protocol. The first dose of study drug at the study center was administered at a time that allowed for the required 6-hour post-dose monitoring and for additional time for extended monitoring, if necessary. The patient was discharged after specific discharge criteria were met. Dose adjustments were not allowed, but dose interruptions were based on outlined criteria.

    Number of subjects in period 1
    		Fingolimod 0.5mg/Daily
    Started
    2
    Completed
    0
    Not completed
    2
         Administrative problems
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fingolimod 0.5mg/Daily
    Reporting group description
    		 Oral capsule dose was given once daily for 48 weeks

    Reporting group values
    		 Fingolimod 0.5mg/Daily Total
    Number of subjects
    		 2 2
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Fingolimod 0.5mg/Daily
    Reporting group description
    		 Oral capsule dose was given once daily for 48 weeks

    Primary: Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo

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    End point title
    		 Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo [1]
    End point description
    Due to early termination and low patient enrollment the primary outcome measure was not analyzed
    End point type
    Primary
    End point timeframe
    Baseline and Week 18
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to early termination and insufficient patient enrollment the primary outcome measure was not analyzed
    End point values
    		 Fingolimod 0.5mg/Daily
    Number of subjects analysed
    0 [2]
    Units: Participants
    Notes
    [2] - Due to early termination and low patient enrollment the primary outcome measure was not analyzed
    No statistical analyses for this end point

    Secondary: Low Contrast Visual Acuity (LCVA)

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    End point title
    		 Low Contrast Visual Acuity (LCVA)
    End point description
    Due to early termination and low patient enrollment this trial was not powered for efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Fingolimod 0.5mg/Daily
    Number of subjects analysed
    0 [3]
    Units: Participants
    Notes
    [3] - Due to early termination and low patient enrollment this trial was not powered for efficacy
    No statistical analyses for this end point

    Secondary: Vision Based Quality of Life (QoL) Utility Score

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    End point title
    		 Vision Based Quality of Life (QoL) Utility Score
    End point description
    Due to early termination and low patient enrollment this trial was not powered for efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 18, Week 48
    End point values
    		 Fingolimod 0.5mg/Daily
    Number of subjects analysed
    0 [4]
    Units: Participants
    Notes
    [4] - Due to early termination and low patient enrollment this trial was not powered for efficacy.
    No statistical analyses for this end point

    Secondary: Proportion of Patients Converting to Either 2005 or 2010 McDonald MS or to CDMS

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    End point title
    		 Proportion of Patients Converting to Either 2005 or 2010 McDonald MS or to CDMS
    End point description
    Due to early termination and low patient enrollment this trial was not powered for efficacy.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 18, Week 48
    End point values
    		 Fingolimod 0.5mg/Daily
    Number of subjects analysed
    0 [5]
    Units: Participants
    Notes
    [5] - Due to early termination and low patient enrollment this trial was not powered for efficacy.
    No statistical analyses for this end point

    Secondary: Number of Particpants With Adverse Events as a Measure of Safety and Tolerability

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    End point title
    		 Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
    End point description
    Number of particpants with Adverse events as a measure of safety and tolerability.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60
    End point values
    		 Fingolimod 0.5mg/Daily
    Number of subjects analysed
    2
    Units: Participants
        Adverse Events (AE)
    1
        Death
    0
        Non-Fatal Serious Adverse Event (SAE)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Fingolimod 0.5 mg/day for 48 weeks (immediate treatment)
    Reporting group description
    		 Fingolimod 0.5 mg/day for 48 weeks (immediate treatment)

    Serious adverse events
    		 Fingolimod 0.5 mg/day for 48 weeks (immediate treatment)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fingolimod 0.5 mg/day for 48 weeks (immediate treatment)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    2

    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.
    In Dec-2013, Novartis reprioritized the global fingolimod clinical program strategy Novartis and decided to halt development of fingolimod for the treatment of ADON, resulting in the discontinuation of this study.
    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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