Effect of F2695 on Functional Recovery After Ischemic Stroke
LIFE
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
2 other identifiers
interventional
532
11 countries
87
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2012
Typical duration for phase_3
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 10, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedApril 1, 2015
March 1, 2014
2.6 years
July 10, 2012
March 31, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12
week 12
Secondary Outcomes (5)
Percentage of patients with NIHSS score less than or equal to 5 at Week 12
week 12
Percentage of patients with at least one moderate to severe depressive
Baseline to week 12
Change from baseline to Week 12 of the mean NIHSS total and motor scores
baseline to week 12
Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests
baseline to week 12
Percentage of patients with a mRS score less than or equal to 2 at Week 12
baseline to week 12
Study Arms (2)
F2695
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (87)
Cliniques Universitaires Saint Luc
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitaire Ziekenhuis Gasthuisberg
Leuven, Belgium
Clinique Saint-Joseph
Liège, Belgium
Regional Ziekenhuis Sint-Trudo
Sint-Truiden, Belgium
Sint-Andriesziekenhuis
Tielt, Belgium
Academisch Ziekenhuis Sint Augustinus
Wilrijk, Belgium
Fakultní nemocnice u sv. Anny v Brne
Brno, Czechia
Fakultní nemocnice Hradec Králové
Hradec Kralové, Czechia
Litomyšlská Nemocnice, a.s.
Litomyšl, Czechia
Fakultní nemocnice Olomouc
Olomouc, Czechia
Fakultní Nemocnice Ostrava
Ostrava, Czechia
Vítkovická nemocnice a.s.
Ostrava - Vítkovice, Czechia
Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
Besançon, France
Clinique des Cèdres
Cornebarrieu, France
Centre Hospitalier de Lens
Lens, France
Hôpital Roger Salengro
Lille, France
Groupe Hospitalier Paris Saint Joseph
Paris, France
Hopital Lariboisière
Paris, France
Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
Poitiers, France
Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord
Saint-Priest-en-Jarez, France
Hôpital Purpan
Toulouse, France
Neurologische Klinik GmbH
Bad Neustadt/Saale, Germany
Universitätsklinik Charité, Campus Mitte
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Universitätsklinikum Essen
Essen, Germany
Freiburger Universitätsklinik
Freiburg im Breisgau, Germany
Asklepios Klinik Altona
Hamburg, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinikum Münster
Münster, Germany
Asklepios Fachklinikum Teupitz
Teupitz, Germany
Jahn Ferenc Dél-pesti Kórház
Budapest, Hungary
Magyar Honvédség Honvédkórház
Budapest, Hungary
Semmelweis Egyetem Neurológiai Klinika
Budapest, Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
Debrecen, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, Hungary
Kaposi Mór Megyei Oktató Kórhaz
Kaposvár, Hungary
BAZ Megyei és Egyetemi Oktató Kórház
Miskolc, Hungary
Kanizsai Dorottya Kórház
Nagykanizsa, Hungary
Jósa András Oktató Kórház
Nyíregyháza, Hungary
Soproni Erzsébet Oktató Kórház
Sopron, Hungary
Fejér Megyei Szent György Kórház
Székesfehérvár, Hungary
Azienda Sanitaria Ospedaliera "San Giovanni Battista"
Foligno, Italy
Azienda Ospedaliera San Gerardo
Monza, Italy
IRCCS "Istituto Neurologico C. Mondino"
Pavia, Italy
Ospedale Santa Maria della Misericordia
Perugia, Italy
IRCCS Fondazione Santa Lucia
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Hospital Garcia de Orta
Almada, Portugal
Hospitais da Universidade de Coimbra
Coimbra, Portugal
Hospital de Santa Maria
Lisbon, Portugal
Centro Hospitalar do Porto / Hospital Geral de Santo António
Porto, Portugal
Hospital de São João
Porto, Portugal
Municipal Healthcare Institution "Municipal Clinical Hospital # 3"
Chelyabinsk, Russia
Professor S.V. Ochapovsky Territorial Clinical Hospital #1
Krasnodar, Russia
Clinical Hospital Number 31
Moscow, Russia
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
Moscow, Russia
Scientific Research Neurology Institute of Russian Academy of Medical Services
Moscow, Russia
State Budget Healthcare Institution "City clinical hospital #20"
Moscow, Russia
State Institution of Healthcare of Moscow City "City Clinical Hospital #61"
Moscow, Russia
State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"
Petersburg Saint, Russia
Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"
Samara, Russia
State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"
Samara, Russia
Smolensk State Medical Academy of RosZdrav
Smolensk, Russia
Bashkirian State Medical University
Ufa, Russia
Regional Hospital #1, Ekaterinburg
Yekaterinburg, Russia
Hospital General de Albacete
Albacete, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario de Girona Doctor Josep Trueta
Girona, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario La Princesa
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Hospital de Tortosa Verge de la Cinta
Tortosa, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain
Danderyds Sjukhus AB
Danderyd, Sweden
Sahlgrenska Universitetsjukhuset
Gothenburg, Sweden
Universitetssjukhuset Linköping
Linköping, Sweden
Skånes Universitetssjukhus i Lund
Lund, Sweden
Mora lasarett
Mora, Sweden
Kärnsjukhuset i Skövde-KSS
Skövde, Sweden
Universitätsspital Basel
Basel, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Klinik Hirslanden
Zurich, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François Chollet
Hôpital Purpan
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2012
First Posted
July 12, 2012
Study Start
July 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
April 1, 2015
Record last verified: 2014-03