Effect of F2695 on Functional Recovery After Ischemic Stroke

NCT ID: NCT01639014

Last Updated: 2015-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

532 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

F2695

Group Type EXPERIMENTAL

F2695

Intervention Type DRUG

75 mg OD in 2 capsules

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

2 capsules

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

F2695

75 mg OD in 2 capsules

Intervention Type DRUG

placebo

2 capsules

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female patient, 18 to 80 years of age
* Confirmed acute ischemic stroke within the past 2 - 10 days
* Unilateral motor deficit,
* National Institutes of Health stroke scale (NIHSS) motor score \>= 5
* Modified Rankin Scale (mRS) of 4 or 5
* Able and willing to comply with the site rehabilitation program requirements

Exclusion Criteria

* Aphasia
* Severe post-stroke condition
* Active depressive episode
* Intra-cerebral hemorrhage
* Use of anti-depressant drugs
* Cardiac rhythm disorder
* Uncontrolled arterial hypertension
* Other severe acute or chronic medical or psychiatric condition.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pierre Fabre Medicament

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

François Chollet

Role: PRINCIPAL_INVESTIGATOR

Hôpital Purpan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cliniques Universitaires Saint Luc

Brussels, , Belgium

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

Universitaire Ziekenhuis Gasthuisberg

Leuven, , Belgium

Site Status

Clinique Saint-Joseph

Liège, , Belgium

Site Status

Regional Ziekenhuis Sint-Trudo

Sint-Truiden, , Belgium

Site Status

Sint-Andriesziekenhuis

Tielt, , Belgium

Site Status

Academisch Ziekenhuis Sint Augustinus

Wilrijk, , Belgium

Site Status

Fakultní nemocnice u sv. Anny v Brne

Brno, , Czechia

Site Status

Fakultní nemocnice Hradec Králové

Hradec Kralové, , Czechia

Site Status

Litomyšlská Nemocnice, a.s.

Litomyšl, , Czechia

Site Status

Fakultní nemocnice Olomouc

Olomouc, , Czechia

Site Status

Fakultní Nemocnice Ostrava

Ostrava, , Czechia

Site Status

Vítkovická nemocnice a.s.

Ostrava - Vítkovice, , Czechia

Site Status

Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon

Besançon, , France

Site Status

Clinique des Cèdres

Cornebarrieu, , France

Site Status

Centre Hospitalier de Lens

Lens, , France

Site Status

Hôpital Roger Salengro

Lille, , France

Site Status

Groupe Hospitalier Paris Saint Joseph

Paris, , France

Site Status

Hopital Lariboisière

Paris, , France

Site Status

Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie

Poitiers, , France

Site Status

Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord

Saint-Priest-en-Jarez, , France

Site Status

Hôpital Purpan

Toulouse, , France

Site Status

Neurologische Klinik GmbH

Bad Neustadt/Saale, , Germany

Site Status

Universitätsklinik Charité, Campus Mitte

Berlin, , Germany

Site Status

Universitätsklinikum Bonn

Bonn, , Germany

Site Status

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status

Universitätsklinikum Essen

Essen, , Germany

Site Status

Freiburger Universitätsklinik

Freiburg im Breisgau, , Germany

Site Status

Asklepios Klinik Altona

Hamburg, , Germany

Site Status

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status

Universitätsklinikum Münster

Münster, , Germany

Site Status

Asklepios Fachklinikum Teupitz

Teupitz, , Germany

Site Status

Jahn Ferenc Dél-pesti Kórház

Budapest, , Hungary

Site Status

Magyar Honvédség Honvédkórház

Budapest, , Hungary

Site Status

Semmelweis Egyetem Neurológiai Klinika

Budapest, , Hungary

Site Status

Debreceni Egyetem Orvos- és Egészségtudományi Centrum

Debrecen, , Hungary

Site Status

Petz Aladár Megyei Oktató Kórház

Győr, , Hungary

Site Status

Kaposi Mór Megyei Oktató Kórhaz

Kaposvár, , Hungary

Site Status

BAZ Megyei és Egyetemi Oktató Kórház

Miskolc, , Hungary

Site Status

Kanizsai Dorottya Kórház

Nagykanizsa, , Hungary

Site Status

Jósa András Oktató Kórház

Nyíregyháza, , Hungary

Site Status

Soproni Erzsébet Oktató Kórház

Sopron, , Hungary

Site Status

Fejér Megyei Szent György Kórház

Székesfehérvár, , Hungary

Site Status

Azienda Sanitaria Ospedaliera "San Giovanni Battista"

Foligno, , Italy

Site Status

Azienda Ospedaliera San Gerardo

Monza, , Italy

Site Status

IRCCS "Istituto Neurologico C. Mondino"

Pavia, , Italy

Site Status

Ospedale Santa Maria della Misericordia

Perugia, , Italy

Site Status

IRCCS Fondazione Santa Lucia

Roma, , Italy

Site Status

Istituto Clinico Humanitas

Rozzano, , Italy

Site Status

Hospital Garcia de Orta

Almada, , Portugal

Site Status

Hospitais da Universidade de Coimbra

Coimbra, , Portugal

Site Status

Hospital de Santa Maria

Lisbon, , Portugal

Site Status

Centro Hospitalar do Porto / Hospital Geral de Santo António

Porto, , Portugal

Site Status

Hospital de São João

Porto, , Portugal

Site Status

Municipal Healthcare Institution "Municipal Clinical Hospital # 3"

Chelyabinsk, , Russia

Site Status

Professor S.V. Ochapovsky Territorial Clinical Hospital #1

Krasnodar, , Russia

Site Status

Clinical Hospital Number 31

Moscow, , Russia

Site Status

Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway

Moscow, , Russia

Site Status

Scientific Research Neurology Institute of Russian Academy of Medical Services

Moscow, , Russia

Site Status

State Budget Healthcare Institution "City clinical hospital #20"

Moscow, , Russia

Site Status

State Institution of Healthcare of Moscow City "City Clinical Hospital #61"

Moscow, , Russia

Site Status

State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"

Petersburg Saint, , Russia

Site Status

Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"

Samara, , Russia

Site Status

State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"

Samara, , Russia

Site Status

Smolensk State Medical Academy of RosZdrav

Smolensk, , Russia

Site Status

Bashkirian State Medical University

Ufa, , Russia

Site Status

Regional Hospital #1, Ekaterinburg

Yekaterinburg, , Russia

Site Status

Hospital General de Albacete

Albacete, , Spain

Site Status

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario de Girona Doctor Josep Trueta

Girona, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario La Princesa

Madrid, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, , Spain

Site Status

Hospital de Tortosa Verge de la Cinta

Tortosa, , Spain

Site Status

Hospital Clinico Universitario de Valladolid

Valladolid, , Spain

Site Status

Danderyds Sjukhus AB

Danderyd, , Sweden

Site Status

Sahlgrenska Universitetsjukhuset

Gothenburg, , Sweden

Site Status

Universitetssjukhuset Linköping

Linköping, , Sweden

Site Status

Skånes Universitetssjukhus i Lund

Lund, , Sweden

Site Status

Mora lasarett

Mora, , Sweden

Site Status

Kärnsjukhuset i Skövde-KSS

Skövde, , Sweden

Site Status

Universitätsspital Basel

Basel, , Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Klinik Hirslanden

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Czechia France Germany Hungary Italy Portugal Russia Spain Sweden Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-001592-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

F02695 LP 2 05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Beta Blockers In Acute Ischemic Stroke
NCT01061190 COMPLETED PHASE2/PHASE3
Donepezil Trial for Motor Recovery in Acute Stroke
NCT01442766 WITHDRAWN PHASE1/PHASE2