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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
F2695
placebo
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cliniques Universitaires Saint Luc
  • Universitair Ziekenhuis Gent
  • Universitaire Ziekenhuis Gasthuisberg
  • Clinique Saint-Joseph
  • Regional Ziekenhuis Sint-Trudo
  • Sint-Andriesziekenhuis
  • Academisch Ziekenhuis Sint Augustinus
  • Fakultní nemocnice u sv. Anny v Brne
  • Fakultní nemocnice Hradec Králové
  • Litomyšlská Nemocnice, a.s.
  • Fakultní nemocnice Olomouc
  • Vítkovická nemocnice a.s.
  • Fakultní Nemocnice Ostrava
  • Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
  • Clinique des Cèdres
  • Centre Hospitalier de Lens
  • Hôpital Roger Salengro
  • Groupe Hospitalier Paris Saint Joseph
  • Hopital Lariboisière
  • Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
  • Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord
  • Hôpital Purpan
  • Neurologische Klinik GmbH
  • Universitätsklinik Charité, Campus Mitte
  • Universitätsklinikum Bonn
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Essen
  • Freiburger Universitätsklinik
  • Asklepios Klinik Altona
  • Universitätsklinikum Leipzig
  • Universitätsklinikum Münster
  • Asklepios Fachklinikum Teupitz
  • Jahn Ferenc Dél-pesti Kórház
  • Magyar Honvédség Honvédkórház
  • Semmelweis Egyetem Neurológiai Klinika
  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum
  • Petz Aladár Megyei Oktató Kórház
  • Kaposi Mór Megyei Oktató Kórhaz
  • BAZ Megyei és Egyetemi Oktató Kórház
  • Kanizsai Dorottya Kórház
  • Jósa András Oktató Kórház
  • Soproni Erzsébet Oktató Kórház
  • Fejér Megyei Szent György Kórház
  • Azienda Sanitaria Ospedaliera "San Giovanni Battista"
  • Azienda Ospedaliera San Gerardo
  • IRCCS "Istituto Neurologico C. Mondino"
  • Ospedale Santa Maria della Misericordia
  • IRCCS Fondazione Santa Lucia
  • Istituto Clinico Humanitas
  • Hospital Garcia de Orta
  • Hospitais da Universidade de Coimbra
  • Hospital de Santa Maria
  • Centro Hospitalar do Porto / Hospital Geral de Santo António
  • Hospital de São João
  • Municipal Healthcare Institution "Municipal Clinical Hospital # 3"
  • Regional Hospital #1, Ekaterinburg
  • Professor S.V. Ochapovsky Territorial Clinical Hospital #1
  • Clinical Hospital Number 31
  • Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
  • Scientific Research Neurology Institute of Russian Academy of Medical Services
  • State Budget Healthcare Institution "City clinical hospital #20"
  • State Institution of Healthcare of Moscow City "City Clinical Hospital #61"
  • State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"
  • Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"
  • State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"
  • Smolensk State Medical Academy of RosZdrav
  • Bashkirian State Medical University
  • Hospital General de Albacete
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Santa Creu i Sant Pau
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario de Girona Doctor Josep Trueta
  • Hospital Clínico San Carlos
  • Hospital Universitario La Princesa
  • Hospital Universitario Ramón y Cajal
  • Hospital Clínico Universitario de Santiago de Compostela
  • Hospital de Tortosa Verge de la Cinta
  • Hospital Clinico Universitario de Valladolid
  • Danderyds Sjukhus AB
  • Sahlgrenska Universitetsjukhuset
  • Universitetssjukhuset Linköping
  • Skånes Universitetssjukhus i Lund
  • Mora lasarett
  • Kärnsjukhuset i Skövde-KSS
  • Universitätsspital Basel
  • Centre Hospitalier Universitaire Vaudois
  • Klinik Hirslanden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

F2695

placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12

Secondary Outcome Measures

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

Full Information

First Posted
July 10, 2012
Last Updated
March 31, 2015
Sponsor
Pierre Fabre Medicament
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1. Study Identification

Unique Protocol Identification Number
NCT01639014
Brief Title
Effect of F2695 on Functional Recovery After Ischemic Stroke
Acronym
LIFE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
532 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F2695
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
F2695
Intervention Description
75 mg OD in 2 capsules
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
2 capsules
Primary Outcome Measure Information:
Title
Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Percentage of patients with NIHSS score less than or equal to 5 at Week 12
Time Frame
week 12
Title
Percentage of patients with at least one moderate to severe depressive
Time Frame
Baseline to week 12
Title
Change from baseline to Week 12 of the mean NIHSS total and motor scores
Time Frame
baseline to week 12
Title
Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests
Time Frame
baseline to week 12
Title
Percentage of patients with a mRS score less than or equal to 2 at Week 12
Time Frame
baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Chollet
Organizational Affiliation
Hôpital Purpan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
Country
Belgium
Facility Name
Universitaire Ziekenhuis Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Clinique Saint-Joseph
City
Liege
Country
Belgium
Facility Name
Regional Ziekenhuis Sint-Trudo
City
Sint-Truiden
Country
Belgium
Facility Name
Sint-Andriesziekenhuis
City
Tielt
Country
Belgium
Facility Name
Academisch Ziekenhuis Sint Augustinus
City
Wilrijk
Country
Belgium
Facility Name
Fakultní nemocnice u sv. Anny v Brne
City
Brno
Country
Czech Republic
Facility Name
Fakultní nemocnice Hradec Králové
City
Hradec Kralové
Country
Czech Republic
Facility Name
Litomyšlská Nemocnice, a.s.
City
Litomyšl
Country
Czech Republic
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
Vítkovická nemocnice a.s.
City
Ostrava - Vítkovice
Country
Czech Republic
Facility Name
Fakultní Nemocnice Ostrava
City
Ostrava
Country
Czech Republic
Facility Name
Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
City
Besançon
Country
France
Facility Name
Clinique des Cèdres
City
Cornebarrieu
Country
France
Facility Name
Centre Hospitalier de Lens
City
Lens
Country
France
Facility Name
Hôpital Roger Salengro
City
Lille
Country
France
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
Country
France
Facility Name
Hopital Lariboisière
City
Paris
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
City
Poitiers
Country
France
Facility Name
Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord
City
Saint Priest en Jarez
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
Country
France
Facility Name
Neurologische Klinik GmbH
City
Bad Neustadt/Saale
Country
Germany
Facility Name
Universitätsklinik Charité, Campus Mitte
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Freiburger Universitätsklinik
City
Freiburg
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
Asklepios Fachklinikum Teupitz
City
Teupitz
Country
Germany
Facility Name
Jahn Ferenc Dél-pesti Kórház
City
Budapest
Country
Hungary
Facility Name
Magyar Honvédség Honvédkórház
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem Neurológiai Klinika
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
City
Debrecen
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Gyor
Country
Hungary
Facility Name
Kaposi Mór Megyei Oktató Kórhaz
City
Kaposvár
Country
Hungary
Facility Name
BAZ Megyei és Egyetemi Oktató Kórház
City
Miskolc
Country
Hungary
Facility Name
Kanizsai Dorottya Kórház
City
Nagykanizsa
Country
Hungary
Facility Name
Jósa András Oktató Kórház
City
Nyíregyháza
Country
Hungary
Facility Name
Soproni Erzsébet Oktató Kórház
City
Sopron
Country
Hungary
Facility Name
Fejér Megyei Szent György Kórház
City
Székesfehérvár
Country
Hungary
Facility Name
Azienda Sanitaria Ospedaliera "San Giovanni Battista"
City
Foligno
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
Country
Italy
Facility Name
IRCCS "Istituto Neurologico C. Mondino"
City
Pavia
Country
Italy
Facility Name
Ospedale Santa Maria della Misericordia
City
Perugia
Country
Italy
Facility Name
IRCCS Fondazione Santa Lucia
City
Roma
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Facility Name
Hospital Garcia de Orta
City
Almada
Country
Portugal
Facility Name
Hospitais da Universidade de Coimbra
City
Coimbra
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisboa
Country
Portugal
Facility Name
Centro Hospitalar do Porto / Hospital Geral de Santo António
City
Porto
Country
Portugal
Facility Name
Hospital de São João
City
Porto
Country
Portugal
Facility Name
Municipal Healthcare Institution "Municipal Clinical Hospital # 3"
City
Chelyabinsk
Country
Russian Federation
Facility Name
Regional Hospital #1, Ekaterinburg
City
Ekaterinburg
Country
Russian Federation
Facility Name
Professor S.V. Ochapovsky Territorial Clinical Hospital #1
City
Krasnodar
Country
Russian Federation
Facility Name
Clinical Hospital Number 31
City
Moscow
Country
Russian Federation
Facility Name
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
City
Moscow
Country
Russian Federation
Facility Name
Scientific Research Neurology Institute of Russian Academy of Medical Services
City
Moscow
Country
Russian Federation
Facility Name
State Budget Healthcare Institution "City clinical hospital #20"
City
Moscow
Country
Russian Federation
Facility Name
State Institution of Healthcare of Moscow City "City Clinical Hospital #61"
City
Moscow
Country
Russian Federation
Facility Name
State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"
City
Petersburg Saint
Country
Russian Federation
Facility Name
Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"
City
Samara
Country
Russian Federation
Facility Name
State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"
City
Samara
Country
Russian Federation
Facility Name
Smolensk State Medical Academy of RosZdrav
City
Smolensk
Country
Russian Federation
Facility Name
Bashkirian State Medical University
City
Ufa
Country
Russian Federation
Facility Name
Hospital General de Albacete
City
Albacete
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Girona Doctor Josep Trueta
City
Gerona
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital de Tortosa Verge de la Cinta
City
Tortosa
Country
Spain
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
Country
Spain
Facility Name
Danderyds Sjukhus AB
City
Danderyd
Country
Sweden
Facility Name
Sahlgrenska Universitetsjukhuset
City
Göteborg
Country
Sweden
Facility Name
Universitetssjukhuset Linköping
City
Linköping
Country
Sweden
Facility Name
Skånes Universitetssjukhus i Lund
City
Lund
Country
Sweden
Facility Name
Mora lasarett
City
Mora
Country
Sweden
Facility Name
Kärnsjukhuset i Skövde-KSS
City
Skövde
Country
Sweden
Facility Name
Universitätsspital Basel
City
Basel
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
Country
Switzerland
Facility Name
Klinik Hirslanden
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

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Effect of F2695 on Functional Recovery After Ischemic Stroke

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