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    Clinical Trial Results:
    Etude préliminaire de l’efficacité d’un α1 bloquant (la prazosine) en prévention de la survenue d’un état de stress post-traumatique chez des patients présentant un état de stress aigu.

    Summary
    EudraCT number
    		 2016-004653-32
    Trial protocol
    		 FR  
    Global end of trial date
    30 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2021
    First version publication date
    22 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    69HCL16_0628
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hospices Civils de Lyon
    Sponsor organisation address
    3, Quai des Célestins, LYON, France, 69002
    Public contact
    Direction de la Recherche Clinique , Hospices Civils de Lyon, +33 472406 842, cecile.riera@chu-lyon.fr
    Scientific contact
    Direction de la Recherche Clinique , Hospices Civils de Lyon, +33 472406 842, cecile.riera@chu-lyon.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
    15 Aug 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Tester l’efficacité de la prazosine en cure courte chez des patients présentant un ESA afin de prévenir le développement d’un ESPT à 6 mois évalué par l’échelle CAPS.
    Protection of trial subjects
    Respect des critères d'éligibilité et des procédures du protocole ; notification des EI et EIG au promoteur ; assurance qualité (monitoring) assurée par le promoteur sur l'ensemble des dossiers patients
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2017
    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: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were screened either during their visit to an emergency department or during hospitalization or consultation or at the medico-judicial unit (for juridical procedure following an assault or an accident). If an ASD was diagnosed, patients were referred to the study inclusion consultation between 3 and 7 days after the event.

    Pre-assignment
    Screening details
    		 Patients were screened either during their visit to an emergency department, or during hospitalization or consultation at the Hospices Civils de Lyon, or at the medico-judicial unit. If an ASD was diagnosed, patients were referred to the study inclusion consultation between 3 and 7 days after the event.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Prazosin, ALPRESS® LP 2,5 et 5 mg
    Arm description
    		 Patients included in this study will be adults with acute stress as a result of a direct experience traumatic event. They will be treated with Prazosin, ALPRESS® LP 2,5 et 5 mg during 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALPRESS XR 2.5 mg (Prazozine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    -PERIOD 1 (D0-D7): 1 tablet of ALPRESS XR 2.5 mg (Prazozine) at bedtime for 7 days

    Investigational medicinal product name
    ALPRESS XR 5 mg (Prazozine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    - PERIOD 2 (D8-D27): 1 morning tablet of ALPRESS XR 5 mg (Prazozine) at bedtime for 21 days

    Number of subjects in period 1
    		Prazosin, ALPRESS® LP 2,5 et 5 mg
    Started
    15
    Completed
    8
    Not completed
    7
         Lost to follow-up
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    The mean age was 30,2 years old and the median age 26 years old with a range from 18 to 48 years old.
    Units: years
        arithmetic mean (full range (min-max))
    		 30.2 (18 to 48) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Prazosin, ALPRESS® LP 2,5 et 5 mg
    Reporting group description
    		 Patients included in this study will be adults with acute stress as a result of a direct experience traumatic event. They will be treated with Prazosin, ALPRESS® LP 2,5 et 5 mg during 28 days.

    Primary: Presence of PTSD

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    End point title
    		 Presence of PTSD [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: No statistical analyses have been conducted for this primary end point ; only descriptive analyses have been performed.
    End point values
    		 Prazosin, ALPRESS® LP 2,5 et 5 mg
    Number of subjects analysed
    8
    Units: number of events
    2
    Attachments
    		 Untitled (Filename: Flowchart PRAZOSTRESS.docx)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    7 days, 14 days, 1 month, 3 months, 6 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    ALPRESS XR 2.5 or 5 mg (Prazozine)
    Reporting group description
    		 -

    Serious adverse events
    		 ALPRESS XR 2.5 or 5 mg (Prazozine)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ALPRESS XR 2.5 or 5 mg (Prazozine)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 15 (60.00%)
    Nervous system disorders
    Vertigo positional
         subjects affected / exposed
    9 / 15 (60.00%)
         occurrences all number
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Mar 2019
    - extension of recruitment period (6 months) ; - modification of inclusion criteria : patients can be included up to 14 days after trauma, instead of 7 days

    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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