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    Clinical Trial Results:
    Evaluation de l'intérêt d'un traitement par hydroquinidine pour la prise en charge des patients atteints d'un syndrome de Brugada à risque rythmique élevé et implantés d'un défibrillateur

    Summary
    EudraCT number
    		 2008-000994-39
    Trial protocol
    		 FR  
    Global end of trial date
    20 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jul 2023
    First version publication date
    20 Jul 2023
    Other versions
    Summary report(s)
    		 Summary final report

    Trial information

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    Trial identification
    Sponsor protocol code
    BRD 06/2-D
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00927732
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Hospitalier et Universitaire de Nantes
    Sponsor organisation address
    1 place Alexis Ricordeau, Nantes, France, 44093
    Public contact
    Mme Monique MARGUERITE, Centre Hospitalier et Universitaire de Nantes, +33 253482832, monique.marguerite@chu-nantes.fr
    Scientific contact
    Mme Monique MARGUERITE, Centre Hospitalier et Universitaire de Nantes, +33 253482832, monique.marguerite@chu-nantes.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
    18 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare for patients with Brugada syndrome having an Implantable Automatic Defibrillator (IAD) the time length before the happening of an appropriate electric shock registered on the IAD when they are under hydroquinidine treatment or when they are under placebo (double-blinded cross-over study design)
    Protection of trial subjects
    During and after each injection, patients were carefully monitored.
    Background therapy
    		 Patients receive background therapy in the form of a cardiac defibrillator in connection with their pathology (Brugada syndrome)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Feb 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)
    45
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 With the inclusion riteria we have adopted, fifty evaluable patients will therefore be required. Total duration : 6 years Recruitment period : 3 years Duration of treatment per patient : 18 months Follow-up time per patient : 3 years

    Pre-assignment
    Screening details
    		 Patient interview Clinical examination of the patient Collection of an ECG with an appearance of spontaneous type I Brugada syndrome recorded during the consultation or during a previous consultation. A copy of this ECG will be promptly sent to the experts on the scientific committee for confirmation of Brugada syndrome. Patients enrolled in the

    Period 1
    Period 1 title
    Phase I
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Hydroquinidine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Serecor
    Investigational medicinal product code
    Other name
    HYDROQUINIDINE
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    300 mg

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    the placebo has the same shape as the treatment capsule, but contains only sugar (sucrose and corn starch)

    Number of subjects in period 1
    		Hydroquinidine Placebo
    Started
    26
    24
    Completed
    16
    21
    Not completed
    10
    3
         Consent withdrawn by subject
    1
    2
         death not caused by the study (accident)
    1
    -
         Adverse event, non-fatal
    8
    1
    Period 2
    Period 2 title
    Phase II
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Hydroquinidine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Serecor
    Investigational medicinal product code
    Other name
    HYDROQUINIDINE
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    300 mg

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    the placebo has the same shape as the treatment capsule, but contains only sugar (sucrose and corn starch)

    Number of subjects in period 2
    		Hydroquinidine Placebo
    Started
    21
    16
    Completed
    13
    13
    Not completed
    8
    3
         Adverse event, non-fatal
    6
    -
         symptoms not related to treatment
    2
    2
         death not rythmic
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Hydroquinidine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Hydroquinidine Placebo Total
    Number of subjects
    		 26 24 50
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 23 22 45
        From 65-84 years
    		 3 2 5
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 52.5 (22 to 75) 52.4 (25 to 73) -
    Gender categorical
    Sex of patients is not done
    Units: Subjects
        Female
    		 4 5 9
        Male
    		 22 19 41
    Subject analysis sets

    Subject analysis set title
    patient with complete data
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    It's all patients with their data entire completed

    Subject analysis sets values
    		 patient with complete data
    Number of subjects
    26
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    45
        From 65-84 years
    5
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    52.5 (22 to 75)
    Gender categorical
    Sex of patients is not done
    Units: Subjects
        Female
    4
        Male
    22

    End points

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    End points reporting groups
    Reporting group title
    Hydroquinidine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Hydroquinidine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    patient with complete data
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    It's all patients with their data entire completed

    Primary: evaluation of the extension of pre-shock follow-up time by quinidine therapy in patients with Brugada syndrome and defibrillator therapy.

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    End point title
    		 evaluation of the extension of pre-shock follow-up time by quinidine therapy in patients with Brugada syndrome and defibrillator therapy. [1]
    End point description
    End point type
    Primary
    End point timeframe
    The primary endpoint of the study will be the delay in the occurrence of an appropriate electric shock authenticated on the defibrillator's memory.
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: I confirm this answer
    End point values
    		 Hydroquinidine Placebo patient with complete data
    Number of subjects analysed
    26
    16
    26
    Units: Time
        number (not applicable)
    26
    16
    26
    Statistical analysis title
    		 Test Jung
    Statistical analysis description
    To assess the primary endpoint, we will use the Jung test.
    Comparison groups
    Hydroquinidine v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 > 1
    Method
    		 Test JUNG
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    These serious unexpected adverse events will be reported to the competent authorities within 7 or 15 days of the sponsor becoming aware of them.
    Adverse event reporting additional description
    All adverse effects or events encountered during the study, which are observed by the physician or reported by the patient, will be recorded in the observation book in the section provided for this purpose. All serious adverse effects or events will be reported by the sponsor to the competent authorities in accordance with current regulations.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7
    Reporting groups
    Reporting group title
    Hydroquinidine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Hydroquinidine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 26 (26.92%)
    6 / 24 (25.00%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Ventricular probe change
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chest pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Discomfort on exertion with mediosternal pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    DAI change
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic beain injury/bleeding
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Oeasophageagal tumor recurrence
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguenal hernia
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash erythematous
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Intolerance to treatment
    Additional description: Case change
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inapropriate endocavity electric shock
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Hydroquinidine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 24 (4.17%)
    Investigations
    Probe malfunction
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    VD probe rupture
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    Musculoskeletal and connective tissue disorders
    Hip prothesis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    Low back pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    knee tunnel surgery
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Sep 2008
    Modify the study design before starting double-blind treatment Add a non-inclusion criterion Add the possibility for patients presenting digestive AEs after randomization to remain in the study Modify the organization of treatment delivery from the Hotêl-Dieu pharmacy (Nantes) to the pharmacies of the associated centers Addition of a 17th center Addition and deletion of certain mentions in the protocol
    21 Feb 2011
    Extension of recruitment period from 2 to 3 years (end February 2012)
    27 Sep 2011
    Possibility of changing dosage Modification of non-inclusion criteria

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    31 Oct 2011
    Enormous recruitment difficulties Expected number of events overestimated Numerous premature study withdrawals Short validity of treatment lts/ logistical and financial burden
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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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