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
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EudraCT number |
2016-004653-32 |
Trial protocol |
FR |
Global end of trial date |
30 Mar 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Dec 2021
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First version publication date |
22 Dec 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
69HCL16_0628
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Hospices Civils de Lyon
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Sponsor organisation address |
3, Quai des Célestins, LYON, France, 69002
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Public contact |
Direction de la Recherche Clinique , Hospices Civils de Lyon, +33 472406 842, cecile.riera@chu-lyon.fr
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Scientific contact |
Direction de la Recherche Clinique , Hospices Civils de Lyon, +33 472406 842, cecile.riera@chu-lyon.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Aug 2021
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Mar 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
15
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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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
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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
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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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)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
-PERIOD 1 (D0-D7): 1 tablet of ALPRESS XR 2.5 mg (Prazozine) at bedtime for 7 days
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Investigational medicinal product name |
ALPRESS XR 5 mg (Prazozine)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
- PERIOD 2 (D8-D27): 1 morning tablet of ALPRESS XR 5 mg (Prazozine) at bedtime for 21 days
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Prazosin, ALPRESS® LP 2,5 et 5 mg
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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. |
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End point title |
Presence of PTSD [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
6 months
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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. |
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Attachments |
Untitled (Filename: Flowchart PRAZOSTRESS.docx) |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
7 days, 14 days, 1 month, 3 months, 6 months
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
23.1
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Reporting groups
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Reporting group title |
ALPRESS XR 2.5 or 5 mg (Prazozine)
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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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 |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |