Clinical Trials Register

Summary
EudraCT Number:	2016-004653-32
Sponsor's Protocol Code Number:	69HCL16_0628
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-03-30
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2016-004653-32

A.3

Full title of the trial

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.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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.

A.3.2

Name or abbreviated title of the trial where available

PRAZOSTRESS

A.4.1

Sponsor's protocol code number

69HCL16_0628

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Hospices Civils de Lyon
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Hospices Civils de Lyon
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospices Civils de Lyon
B.5.2	Functional name of contact point	Direction de la Recherche Clinique
B.5.3	Address:
B.5.3.1	Street Address	3 quai des Célestins
B.5.3.2	Town/ city	Lyon cedex 02
B.5.3.3	Post code	69229
B.5.3.4	Country	France
B.5.4	Telephone number	+33472406 842
B.5.5	Fax number	+33472115 190
B.5.6	E-mail	cecile.riera@chu-lyon.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ALPRESS L.P. 2,5 mg, comprimé osmotique à libération prolongée
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER HOLDING FRANCE
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PRAZOSIN
D.3.9.3	Other descriptive name	PRAZOSIN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04013MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ALPRESS L.P. 5 mg, comprimé osmotique à libération prolongée
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER HOLDING FRANCE
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PRAZOSIN
D.3.9.3	Other descriptive name	PRAZOSIN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04013MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

état de stress aigu à la suite d’un événement traumatisant par expérience directe

E.1.1.1

Medical condition in easily understood language

état de stress aigu à la suite d’un événement traumatisant par expérience directe

E.1.1.2

Therapeutic area

Not possible to specify

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10044541
E.1.2	Term	Traumatic shock
E.1.2	System Organ Class	10022117 - Injury, poisoning and procedural complications

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

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.

E.2.2

Secondary objectives of the trial

- évaluer l’efficacité symptomatique de la prazosine sur les manifestations d’ESA à 14 jours du traumatisme à l’aide des critères DSM
- évaluer la tolérance de la prazosine régulièrement durant le traitement à l’aide d’auto-questionnaires
- évaluer l’impact du traitement par prazosine sur la réduction des complications de l’ESPT à 6 mois à l’aide d’échelles cliniques
- évaluer l’impact du traitement par prazosine sur la qualité de vie des patients à 6 mois
- évaluer l’observance au traitement proposé à l’issue du protocole

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patient d’âge > 18 ans
- Victime d’un traumatisme par expérience directe (accident ou agression physique)
- Présence d’un ESA entre J3 et J7 après le traumatisme selon les critères DSM V
- Accord pour être suivi pendant 6 mois

E.4

Principal exclusion criteria

- Contre-indication à la prazosine : hypotension orthostatique, insuffisance cardiaque droite, prise d’un autre traitement hypotenseur, d’inhibiteurs de la 5-phosphodiestérase (siledénafil ou d’un diurétique, antécédent de syncope ou malaise grave ou non exploré, hypersensibilité connue aux quinazolines.
- Consommation d’alcool et/ou de drogues au moment du traumatisme
- Antécédent de trouble psychotique
- Risque suicidaire défini par un score ≥ à 2 à l’item idées suicidaires de l’inventaire de dépression de Beck (BDI)
- Majeurs protégés sous tutelle ou curatelle
- Persistance d’une blessure menaçant le pronostic vital à J3
- Agression sexuelle
- Seuls les traumatismes crâniens modérés peuvent être inclus et donc sont exclus les patients ayant présenté une perte de conscience supérieure à 30 minutes, un score de Glasgow inférieur à 13, une amnésie post-traumatique supérieure à 24h (Ruff et al., 2009).
- Prescription de morphine ou dérivé morphinique en cours
- Grossesse ou période d’allaitement
- Dysfonction hépatique connue
- Narcolepsie (maladie de Gélineau)
- Antécédents cardiaques ou vasculaires notamment coronaropathie
- Régime hyposodé strict

E.5 End points

E.5.1

Primary end point(s)

Présence ou non d’un ESPT à 6 mois évalué par l’échelle CAPS (Clinician Administered PTSD Scale)

E.5.1.1

Timepoint(s) of evaluation of this end point

6 mois après l'inclusion

E.5.2

Secondary end point(s)

- La persistance ou non des symptômes d’ESA selon le DSM V
- La présence d’effets secondaires de la prazosine
- La survenue de complications éventuelles de l’ESPT : tentative de suicide, idées suicidaires, addictions, dépression (MADRS).
- La qualité de vie (échelle SF36).
- L’observance du traitement

E.5.2.1

Timepoint(s) of evaluation of this end point

- La persistance ou non des symptômes d’ESA selon le DSM V à J14 post-inclusion, évalués dans un entretien structuré.
- La présence d’effets secondaires de la prazosine évalués à l’aide d’un auto-questionnaire sur les symptômes d’hypotension (vertiges, acouphènes, sensation de faiblesse, voile noir devant les yeux, phosphène, malaise, perte de connaissance) et d’une mesure tensionnelle à chaque consultation.
- La survenue de complications éventuelles de l’ESPT à 6 mois : tentative de suicide, idées suicidaires, addictions, dépression (MADRS).
- La qualité de vie sera évaluée à 6 mois par l’échelle SF36.
- L’observance sera évaluée par comptabilisation des comprimés consommés et non consommés à l’issue du traitement

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Etude prospective

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Dernière visite du dernier patient

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-03-30.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Aucun

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-01-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-03-30

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials