Effect of F2695 on Functional Recovery After Ischemic Stroke (LIFE)

March 31, 2015 updated by: Pierre Fabre Medicament

Effect of 3-month Treatment With F2695 (75mg OD) on Improving Functional Recovery of Patients With Ischemic Stroke. A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-Controlled Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

532

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Cliniques Universitaires Saint Luc
      • Ghent, Belgium
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium
        • Universitaire Ziekenhuis Gasthuisberg
      • Liege, Belgium
        • Clinique Saint-Joseph
      • Sint-Truiden, Belgium
        • Regional Ziekenhuis Sint-Trudo
      • Tielt, Belgium
        • Sint-Andriesziekenhuis
      • Wilrijk, Belgium
        • Academisch Ziekenhuis Sint Augustinus
  • Czech Republic
      • Brno, Czech Republic
        • Fakultni nemocnice u sv. Anny v Brne
      • Hradec Kralové, Czech Republic
        • Fakultni nemocnice Hradec Kralove
      • Litomyšl, Czech Republic
        • Litomyslská nemocnice, a.s.
      • Olomouc, Czech Republic
        • Fakultni Nemocnice Olomouc
      • Ostrava, Czech Republic
        • Fakultni Nemocnice Ostrava
      • Ostrava - Vítkovice, Czech Republic
        • Vitkovicka nemocnice a.s.
  • France
      • Besançon, France
        • Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
      • Cornebarrieu, France
        • Clinique des Cèdres
      • Lens, France
        • Centre Hospitalier de LENS
      • Lille, France
        • Hôpital Roger Salengro
      • Paris, France
        • Hopital Lariboisiere
      • Paris, France
        • Groupe hospitalier Paris saint Joseph
      • Poitiers, France
        • Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
      • Saint Priest en Jarez, France
        • Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord
      • Toulouse, France
        • Hopital Purpan
  • Germany
      • Bad Neustadt/Saale, Germany
        • Neurologische Klinik GmbH
      • Berlin, Germany
        • Universitätsklinik Charité, Campus Mitte
      • Bonn, Germany
        • Universitätsklinikum Bonn
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Essen, Germany
        • Universitätsklinikum Essen
      • Freiburg, Germany
        • Freiburger Universitätsklinik
      • Hamburg, Germany
        • Asklepios Klinik Altona
      • Leipzig, Germany
        • Universitätsklinikum Leipzig
      • Münster, Germany
        • Universitätsklinikum Münster
      • Teupitz, Germany
        • ASKLEPIOS Fachklinikum Teupitz
  • Hungary
      • Budapest, Hungary
        • Magyar Honvédség Honvédkorház
      • Budapest, Hungary
        • Jahn Ferenc Dél-Pesti Kórház
      • Budapest, Hungary
        • Semmelweis Egyetem Neurologiai Klinika
      • Debrecen, Hungary
        • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
      • Gyor, Hungary
        • Petz Aladar Megyei Oktato Korhaz
      • Kaposvár, Hungary
        • Kaposi Mór Megyei Oktató Kórhaz
      • Miskolc, Hungary
        • BAZ Megyei és Egyetemi Oktató Kórház
      • Nagykanizsa, Hungary
        • Kanizsai Dorottya Korhaz
      • Nyíregyháza, Hungary
        • Jósa András Oktató Kórház
      • Sopron, Hungary
        • Soproni Erzsébet Oktató Kórház
      • Székesfehérvár, Hungary
        • Fejer Megyei Szent Gyorgy Korhaz
  • Italy
      • Foligno, Italy
        • Azienda Sanitaria Ospedaliera "San Giovanni Battista"
      • Monza, Italy
        • Azienda Ospedaliera San Gerardo
      • Pavia, Italy
        • IRCCS "Istituto Neurologico C. Mondino"
      • Perugia, Italy
        • Ospedale Santa Maria Della Misericordia
      • Roma, Italy
        • Irccs Fondazione Santa Lucia
      • Rozzano, Italy
        • Istituto Clinico Humanitas
  • Portugal
      • Almada, Portugal
        • Hospital Garcia de Orta
      • Coimbra, Portugal
        • Hospitais da universidade de Coimbra
      • Lisboa, Portugal
        • Hospital de Santa Maria
      • Porto, Portugal
        • Centro Hospitalar do Porto / Hospital Geral de Santo António
      • Porto, Portugal
        • Hospital de Sao Joao
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Municipal Healthcare Institution "Municipal Clinical Hospital # 3"
      • Ekaterinburg, Russian Federation
        • Regional Hospital #1, Ekaterinburg
      • Krasnodar, Russian Federation
        • Professor S.V. Ochapovsky Territorial Clinical Hospital #1
      • Moscow, Russian Federation
        • Clinical Hospital Number 31
      • Moscow, Russian Federation
        • Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
      • Moscow, Russian Federation
        • Scientific Research Neurology Institute of Russian Academy of Medical Services
      • Moscow, Russian Federation
        • State Budget Healthcare Institution "City clinical hospital #20"
      • Moscow, Russian Federation
        • State Institution of Healthcare of Moscow City "City Clinical Hospital #61"
      • Petersburg Saint, Russian Federation
        • State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"
      • Samara, Russian Federation
        • Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"
      • Samara, Russian Federation
        • State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"
      • Smolensk, Russian Federation
        • Smolensk State Medical Academy of RosZdrav
      • Ufa, Russian Federation
        • Bashkirian State Medical University
  • Spain
      • Albacete, Spain
        • Hospital General de Albacete
      • Badalona, Spain
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Hospital Santa Creu i Sant Pau
      • Gerona, Spain
        • Hospital Universitario de Girona Doctor Josep Trueta
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario La Princesa
      • Santiago de Compostela, Spain
        • Hospital Clinico Universitario de Santiago de Compostela
      • Tortosa, Spain
        • Hospital de Tortosa Verge de la Cinta
      • Valladolid, Spain
        • Hospital Clinico Universitario de Valladolid
  • Sweden
      • Danderyd, Sweden
        • Danderyds Sjukhus AB
      • Göteborg, Sweden
        • Sahlgrenska Universitetsjukhuset
      • Linköping, Sweden
        • Universitetssjukhuset Linköping
      • Lund, Sweden
        • Skanes Universitetssjukhus I Lund
      • Mora, Sweden
        • Mora Lasarett
      • Skövde, Sweden
        • Kärnsjukhuset i Skövde-KSS
  • Switzerland
      • Basel, Switzerland
        • Universitätsspital Basel
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
      • Zürich, Switzerland
        • Klinik Hirslanden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Drug: placebo
2 capsules
EXPERIMENTAL: F2695
Drug: F2695
75 mg OD in 2 capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12
Time Frame: week 12
week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with NIHSS score less than or equal to 5 at Week 12
Time Frame: week 12
week 12
Percentage of patients with at least one moderate to severe depressive
Time Frame: Baseline to week 12
Baseline to week 12
Change from baseline to Week 12 of the mean NIHSS total and motor scores
Time Frame: baseline to week 12
baseline to week 12
Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests
Time Frame: baseline to week 12
baseline to week 12
Percentage of patients with a mRS score less than or equal to 2 at Week 12
Time Frame: baseline to week 12
baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Investigators

  • Principal Investigator: François Chollet, Hopital Purpan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

July 10, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (ESTIMATE)

July 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F02695 LP 2 05
  • 2012-001592-37 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Stroke

Clinical Trials on F2695

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe