Clinical trial NCT01639014: Effect of F2695 on Functional Recovery After Ischemic Stroke
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Stroke
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2012-07-12
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12
timeFrame: week 12
Secondary outcomes:
measure: Percentage of patients with NIHSS score less than or equal to 5 at Week 12
timeFrame: week 12
measure: Percentage of patients with at least one moderate to severe depressive
timeFrame: Baseline to week 12
measure: Change from baseline to Week 12 of the mean NIHSS total and motor scores
timeFrame: baseline to week 12
measure: Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests
timeFrame: baseline to week 12
measure: Percentage of patients with a mRS score less than or equal to 2 at Week 12
timeFrame: baseline to week 12
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Gasthuisberg
city: Liege
country: Belgium
facility: Clinique Saint-Joseph
city: Sint-Truiden
country: Belgium
facility: Regional Ziekenhuis Sint-Trudo
city: Tielt
country: Belgium
facility: Sint-Andriesziekenhuis
city: Wilrijk
country: Belgium
facility: Academisch Ziekenhuis Sint Augustinus
city: Brno
country: Czech Republic
facility: Fakultní nemocnice u sv. Anny v Brne
city: Hradec Kralové
country: Czech Republic
facility: Fakultní nemocnice Hradec Králové
city: Litomyšl
country: Czech Republic
facility: Litomyšlská Nemocnice, a.s.
city: Olomouc
country: Czech Republic
facility: Fakultní nemocnice Olomouc
city: Ostrava - Vítkovice
country: Czech Republic
facility: Vítkovická nemocnice a.s.
city: Ostrava
country: Czech Republic
facility: Fakultní Nemocnice Ostrava
city: Besançon
country: France
facility: Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Lens
country: France
facility: Centre Hospitalier de Lens
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
city: Paris
country: France
facility: Hopital Lariboisière
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
city: Saint Priest en Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord
city: Toulouse
country: France
facility: Hôpital Purpan
city: Bad Neustadt/Saale
country: Germany
facility: Neurologische Klinik GmbH
city: Berlin
country: Germany
facility: Universitätsklinik Charité, Campus Mitte
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freiburg
country: Germany
facility: Freiburger Universitätsklinik
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Teupitz
country: Germany
facility: Asklepios Fachklinikum Teupitz
city: Budapest
country: Hungary
facility: Jahn Ferenc Dél-pesti Kórház
city: Budapest
country: Hungary
facility: Magyar Honvédség Honvédkórház
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Neurológiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum
city: Gyor
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
city: Kaposvár
country: Hungary
facility: Kaposi Mór Megyei Oktató Kórhaz
city: Miskolc
country: Hungary
facility: BAZ Megyei és Egyetemi Oktató Kórház
city: Nagykanizsa
country: Hungary
facility: Kanizsai Dorottya Kórház
city: Nyíregyháza
country: Hungary
facility: Jósa András Oktató Kórház
city: Sopron
country: Hungary
facility: Soproni Erzsébet Oktató Kórház
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Kórház
city: Foligno
country: Italy
facility: Azienda Sanitaria Ospedaliera "San Giovanni Battista"
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Pavia
country: Italy
facility: IRCCS "Istituto Neurologico C. Mondino"
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Roma
country: Italy
facility: IRCCS Fondazione Santa Lucia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto / Hospital Geral de Santo António
city: Porto
country: Portugal
facility: Hospital de São João
city: Chelyabinsk
country: Russian Federation
facility: Municipal Healthcare Institution "Municipal Clinical Hospital # 3"
city: Ekaterinburg
country: Russian Federation
facility: Regional Hospital #1, Ekaterinburg
city: Krasnodar
country: Russian Federation
facility: Professor S.V. Ochapovsky Territorial Clinical Hospital #1
city: Moscow
country: Russian Federation
facility: Clinical Hospital Number 31
city: Moscow
country: Russian Federation
facility: Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
city: Moscow
country: Russian Federation
facility: Scientific Research Neurology Institute of Russian Academy of Medical Services
city: Moscow
country: Russian Federation
facility: State Budget Healthcare Institution "City clinical hospital #20"
city: Moscow
country: Russian Federation
facility: State Institution of Healthcare of Moscow City "City Clinical Hospital #61"
city: Petersburg Saint
country: Russian Federation
facility: State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"
city: Samara
country: Russian Federation
facility: Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"
city: Samara
country: Russian Federation
facility: State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy of RosZdrav
city: Ufa
country: Russian Federation
facility: Bashkirian State Medical University
city: Albacete
country: Spain
facility: Hospital General de Albacete
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Gerona
country: Spain
facility: Hospital Universitario de Girona Doctor Josep Trueta
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Tortosa
country: Spain
facility: Hospital de Tortosa Verge de la Cinta
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Danderyd
country: Sweden
facility: Danderyds Sjukhus AB
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetsjukhuset
city: Linköping
country: Sweden
facility: Universitetssjukhuset Linköping
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus i Lund
city: Mora
country: Sweden
facility: Mora lasarett
city: Skövde
country: Sweden
facility: Kärnsjukhuset i Skövde-KSS
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zürich
country: Switzerland
facility: Klinik Hirslanden
Study officials:
affiliation: Hôpital Purpan
name: François Chollet
role: PRINCIPAL_INVESTIGATOR
References: