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    Clinical Trial Results:
    Effect of oral CDP-choline on visual function in young amblyopic patients

    Summary
    EudraCT number
    		 2006-006753-27
    Trial protocol
    		 IT  
    Global end of trial date
    01 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Apr 2022
    First version publication date
    29 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    129/2006/O/Sper
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TUBILUX PHARMA
    Sponsor organisation address
    Via Costarica 20/22, Pomezia (RM), Italy, 00071
    Public contact
    Michela Fresina, Ophthalmology Unit University of Bologna Italy, +39 051 2142837, michela.fresina2@unibo.it
    Scientific contact
    Fabio De Gregorio, Tubilux Pharma, +39 3386659374, de_gregorio@tubilux.it
    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?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Verify whether oral administration of CDP-choline improves the visual function in amblyopic patients after 30-day treatment, as already observed after intramuscular administration of 500-1,000 mg of CDP-choline
    Protection of trial subjects
    Informed consent signed by the parent and paper data collection in a supervised enviroment
    Background therapy
    		 No previous treatment for amblyopia No other local or systemic therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2006
    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
    Italy: 67
    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)
    67
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Children suffering from anisometropic or strabismic amblyopia recruited from May 2006 to December 2006 in the Ophthalmology Service of the University of Bologna and the Eye Clinic of the Catholic University of Rome.

    Pre-assignment
    Screening details
    		 Patients of both sexes suffering from anisometropic or strabismic monolateral amblyopia, aged between 5 and 10 years, not previously treated with conventional antiamblyopic therapies.

    Pre-assignment period milestones
    Number of subjects started
    		 67
    Number of subjects completed
    		 67

    Period 1
    Period 1 title
    Visit 1 day 0
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treated patients
    Arm description
    		 Patients treated with CDP-choline (800 mg daily) + 2 h patching daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oral Cytidine-5’-diphosphocoline
    Investigational medicinal product code
    Other name
    CITICOLINE
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    7-28 mg/Kg/daily

    Arm title
    		 Control Group
    Arm description
    		 Patients treated with 2 h patching daily
    Arm type
    		 Adhesive patch

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Treated patients Control Group
    Started
    37
    30
    Completed
    37
    30
    Period 2
    Period 2 title
    Visit 2 day 30
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treated patients
    Arm description
    		 Patients treated with CDP-choline (800 mg daily) + 2 h patching daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oral Cytidine-5’-diphosphocoline
    Investigational medicinal product code
    Other name
    CITICOLINE
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    7-28 mg/Kg/daily

    Arm title
    		 Control Group
    Arm description
    		 Patients treated with 2 h patching daily
    Arm type
    		 Adhesive patch

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Treated patients Control Group
    Started
    37
    30
    Completed
    37
    30
    Period 3
    Period 3 title
    Visit 3 day 90
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treated patients
    Arm description
    		 Patients treated with CDP-choline (800 mg daily) + 2 h patching daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oral Cytidine-5’-diphosphocoline
    Investigational medicinal product code
    Other name
    CITICOLINE
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    7-28 mg/Kg/daily

    Arm title
    		 Control Group
    Arm description
    		 Patients treated with 2 h patching daily
    Arm type
    		 Adhesive patch

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Treated patients Control Group
    Started
    37
    30
    Completed
    32
    29
    Not completed
    5
    1
         Drop out for reasons no related to the treatment
    5
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treated patients
    Reporting group description
    		 Patients treated with CDP-choline (800 mg daily) + 2 h patching daily

    Reporting group title
    Control Group
    Reporting group description
    		 Patients treated with 2 h patching daily

    Reporting group values
    		 Treated patients Control Group Total
    Number of subjects
    		 37 30 67
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 37 30 67
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 5.9 (5 to 10) 6.2 (5 to 10) -
    Gender categorical
    Units: Subjects
        Female
    		 21 16 37
        Male
    		 16 14 30

    End points

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    End points reporting groups
    Reporting group title
    Treated patients
    Reporting group description
    		 Patients treated with CDP-choline (800 mg daily) + 2 h patching daily

    Reporting group title
    Control Group
    Reporting group description
    		 Patients treated with 2 h patching daily
    Reporting group title
    Treated patients
    Reporting group description
    		 Patients treated with CDP-choline (800 mg daily) + 2 h patching daily

    Reporting group title
    Control Group
    Reporting group description
    		 Patients treated with 2 h patching daily
    Reporting group title
    Treated patients
    Reporting group description
    		 Patients treated with CDP-choline (800 mg daily) + 2 h patching daily

    Reporting group title
    Control Group
    Reporting group description
    		 Patients treated with 2 h patching daily

    Primary: Change in visual acuity (BCVA) of amblyopic eyes measured by Snellen's E chart

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    End point title
    		 Change in visual acuity (BCVA) of amblyopic eyes measured by Snellen's E chart
    End point description
    End point type
    Primary
    End point timeframe
    Data were collected in 3 time points: Visit 1: baseline data were collected Visit 2: after 30 days of treatment Visit 3: after 90 days (the treatment was discontinued in the last 60 days)
    End point values
    		 Treated patients Control Group Treated patients Control Group Treated patients Control Group
    Number of subjects analysed
    37
    30
    37
    30
    32
    29
    Units: LogMAR
        arithmetic mean (standard deviation)
    0.34 ( 0.22 )
    0.26 ( 0.19 )
    0.16 ( 0.15 )
    0.09 ( 0.09 )
    0.14 ( 0.15 )
    0.13 ( 0.15 )
    Statistical analysis title
    		 Two-way ANOVA
    Comparison groups
    Treated patients v Treated patients v Control Group v Treated patients v Control Group v Control Group
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Tukey's test
    Comparison groups
    Control Group v Treated patients v Control Group v Treated patients
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Tukey's test
    Confidence interval

    Secondary: BCVA of healthy eyes measured by isolated E letters (Snellen’s E chart)

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    End point title
    		 BCVA of healthy eyes measured by isolated E letters (Snellen’s E chart)
    End point description
    End point type
    Secondary
    End point timeframe
    Data were collected in 3 time points: Visit 1: baseline data were collected Visit 2: after 30 days of treatment Visit 3: after 90 days (the treatment was discontinued in the last 60 days)
    End point values
    		 Treated patients Control Group Treated patients Control Group Treated patients Control Group
    Number of subjects analysed
    37
    30
    37
    30
    32
    29
    Units: LogMAR
        arithmetic mean (standard deviation)
    0.07 ( 0.09 )
    0.02 ( 0.06 )
    0.04 ( 0.06 )
    0.01 ( 0.02 )
    0.04 ( 0.08 )
    0.01 ( 0.02 )
    Statistical analysis title
    		 Two-way ANOVA
    Comparison groups
    Treated patients v Control Group v Treated patients v Control Group v Treated patients v Control Group
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Tukey's test
    Comparison groups
    Treated patients v Control Group v Treated patients v Control Group
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Tukey's test
    Confidence interval

    Secondary: BCVA of amblyopic eyes measured by isolated E letters

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    End point title
    		 BCVA of amblyopic eyes measured by isolated E letters
    End point description
    End point type
    Secondary
    End point timeframe
    Data were collected in 3 time points: Visit 1: baseline data were collected Visit 2: after 30 days of treatment Visit 3: after 90 days (the treatment was discontinued in the last 60 days)
    End point values
    		 Treated patients Control Group Treated patients Control Group Treated patients Control Group
    Number of subjects analysed
    37
    30
    37
    30
    32
    29
    Units: LogMAR
        arithmetic mean (standard deviation)
    0.21 ( 0.26 )
    0.17 ( 0.21 )
    0.08 ( 0.14 )
    0.03 ( 0.08 )
    0.05 ( 0.12 )
    0.06 ( 0.13 )
    Statistical analysis title
    		 Two-way ANOVA
    Comparison groups
    Treated patients v Control Group v Treated patients v Control Group v Treated patients v Control Group
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Tukey's test
    Comparison groups
    Treated patients v Control Group v Treated patients v Control Group
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Tukey's test
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Throughout the entire timeframe of the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: No adverse reaction to CDP-choline, either minor or serious, was reported throughout the trial. The safety of the treatment was judged to be excellent by the investigators.

    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 reported
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    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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