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    Clinical Trial Results:
    ACTION OF THE AMANTADINE ON POST STROKE APHASIC PATIENTS LANGUAGE AND COMMUNICATION

    Summary
    EudraCT number
    		 2008-003945-10
    Trial protocol
    		 FR  
    Global end of trial date
    04 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2022
    First version publication date
    29 Jun 2022
    Other versions
    Summary report(s)
    		 end study

    Trial information

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    Trial identification
    Sponsor protocol code
    01-APN-08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    chu de nice
    Sponsor organisation address
    DRCI-Hôpital de Cimiez - 4 avenue reine victoria, Nice, France, 06003
    Public contact
    Directeur de la DRCI, CHU de Nice - DRCI, +33 492034589, caillon.c@chu-nice.fr
    Scientific contact
    Investigateur Principal, CHU de Nice - Pr Chatel, 0033 492034011, caillon.c@chu-nice.fr
    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
    04 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm by a «drug test", using amantadine as dopamine agonist, the possibility of significantly improving the verbal fluency and communication of patients with "not fluent" aphasia at the chronic stage when logopedic rehabilitation is "stabilized" (> 6months).
    Protection of trial subjects
    Patients had an expressive aphasia caused by a cerebrovascular accident. The stroke had to have occurred at least six months previously, with no historical limit. Patients with many years of aphasia were equally eligible. All patients had undergone investigations to establish the extent of the stroke, any underlying risk factors at the time of the stroke, and had had rehabilitation that included speech therapy subsequently. Their recovery was considered stable with no progression.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Nov 2009
    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
    France: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion period

    Period 1
    Period 1 title
    Inclusion period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 0Amantadine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amantadine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    3 days Amantadine, 4 days de wash out and 3 days Placebo

    Number of subjects in period 1
    		0Amantadine
    Started
    50
    Completed
    50

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    0Amantadine
    Reporting group description
    		 -

    Subject analysis set title
    50
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    An intention-to-treat analysis was performed (each patient having taken at least one treatment dose), using an analysis of variance, after verification of the absence of carry-over effect, taking into account the sequence effect (the order of administration of treatment) and the period effect.

    Primary: the verbal fluency

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    End point title
    		 the verbal fluency [1]
    End point description
    Fluency was studied according to its two components, lexical and semantic.
    End point type
    Primary
    End point timeframe
    2 years
    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: The statistical analysis of the main criterion is described in the attached document
    End point values
    		 0Amantadine
    Number of subjects analysed
    50
    Units: Number
    50
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Thirteen secondary effects were observed, 11 during placebo treatment of which 2 [diarrhea and malaise] were recorded as severe and led to the withdrawal of these patients from the study, and 2 during amantadine treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Frequency threshold for reporting non-serious adverse events: 1%
    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 2 adverse events are diarrhea and are not considered serious. Treatment has been stopped.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jun 2009
    add test on visit
    05 Nov 2010
    Prolongation study

    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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