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    Clinical Trial Results:
    A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease

    Summary
    EudraCT number
    		 2011-001148-31
    Trial protocol
    		 GB  
    Global end of trial date
    04 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Mar 2020
    First version publication date
    25 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    11/SC/0101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01539837
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Professor David Dexter, Imperial College London, +44 (0)20 7594 6665, d.dexter@imperial.ac.uk
    Scientific contact
    Professor David Dexter, Imperial College London, +44 (0)20 7594 6665, d.dexter@imperial.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
    08 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether 6 month treatment with Deferiprone is well tolerated by PD patients and assess whether such treatment removes excess iron in the brain area affected in PD, the substantia nigra, as assessed by MRI.
    Protection of trial subjects
    Anti-Parkinsonian medication dosages were maintained at a constant level for each individual throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    10
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 22 participants were recruited by between 18/04/2012 – 27/03/2013

    Pre-assignment
    Screening details
    		 The original group of 22 patients, 19 completed the 6-month course of deferiprone, with three brain MRI scans, at 0, 3 and 6 months.

    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, Carer
    Blinding implementation details
    The code for the randomisation was only disclosed at the conclusion of the trial or if the patient experienced unexpected adverse side effects. Patients, care providers and those assessing clinical outcomes were blinded to the intervention given.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Feriprox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg/kg/day for 6 month

    Arm title
    		 Deferiprone 20mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferiprone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg/kg/day for 6 months

    Arm title
    		 Deferiprone 30mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferiprone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30mg/kg/day for 6 months

    Number of subjects in period 1
    		Placebo Deferiprone 20mg Deferiprone 30mg
    Started
    8
    7
    7
    Completed
    8
    6
    5
    Not completed
    0
    1
    2
         bad compliance
    -
    -
    1
         reduce neutrophil level
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo

    Reporting group title
    Deferiprone 20mg
    Reporting group description
    		 -

    Reporting group title
    Deferiprone 30mg
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Deferiprone 20mg Deferiprone 30mg Total
    Number of subjects
    		 8 7 7 22
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 1 5 8
        From 65-84 years
    		 6 6 2 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.38 ± 3.23 68.57 ± 2.17 62.85 ± 2.74 -
    Gender categorical
    Units: Subjects
        Female
    		 5 3 2 10
        Male
    		 3 4 5 12
    Parkinson’s disease duration
    Units: years
        arithmetic mean (standard deviation)
    		 3.54 ± 0.34 2.82 ± 0.69 3.02 ± 2.69 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo

    Reporting group title
    Deferiprone 20mg
    Reporting group description
    		 -

    Reporting group title
    Deferiprone 30mg
    Reporting group description
    		 -

    Primary: Numbers of Serious Adverse Event

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    End point title
    		 Numbers of Serious Adverse Event [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    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: Pilot study, low participants number, no statistical analyses.
    End point values
    		 Placebo Deferiprone 20mg Deferiprone 30mg
    Number of subjects analysed
    8
    7
    7
    Units: Number of participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Iron Concentrations in the Dentate Nucleus

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    End point title
    		 Iron Concentrations in the Dentate Nucleus
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Placebo Deferiprone 20mg Deferiprone 30mg
    Number of subjects analysed
    8
    7
    7
    Units: T2*ms
        arithmetic mean (standard error)
    30.74 ± 0.65
    30.59 ± 0.87
    29.86 ± 1.10
    Statistical analysis title
    		 Iron Concentrations in the Dentate Nucleus
    Comparison groups
    Deferiprone 20mg v Deferiprone 30mg v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 Pairwise comparisons,post-hoc Bonferoni
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo

    Reporting group title
    Deferiprone 20mg
    Reporting group description
    		 -

    Reporting group title
    Deferiprone 30mg
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Deferiprone 20mg Deferiprone 30mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Deferiprone 20mg Deferiprone 30mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    6 / 7 (85.71%)
    6 / 7 (85.71%)
    Blood and lymphatic system disorders
    Decline in white cell counts
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    1
    Gastrointestinal disorders
    Gastrointestinal upset
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    2 / 7 (28.57%)
         occurrences all number
    0
    1
    2
    Musculoskeletal and connective tissue disorders
    Muscular joint pain
         subjects affected / exposed
    0 / 8 (0.00%)
    4 / 7 (57.14%)
    3 / 7 (42.86%)
         occurrences all number
    0
    4
    3

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28469157
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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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