Effect of F2695 on Functional Recovery After Ischemic Stroke

Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639014
• Other study ID #: F02695 LP 2 05
• Secondary ID: 2012-001592-37
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2012
• Last updated: March 31, 2015
• Start date: July 2012
• Est. completion date: February 2015

Study information

• Verified date: March 2014
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéCzech Republic: State Institute for Drug ControlGermany: Paul-Ehrlich-InstitutSpain: Agencia Española de Medicamentos y Productos SanitariosBelgium: Federal Agency for Medicinal Products and Health ProductsHungary: National Institute of PharmacyItaly: National Institute of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Portugal: National Pharmacy and Medicines InstituteSweden: Medical Products AgencySwitzerland: SwissmedicRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• F2695
75 mg OD in 2 capsules
• placebo
2 capsules

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	Universitair Ziekenhuis Gent	Ghent
Belgium	Universitaire Ziekenhuis Gasthuisberg	Leuven
Belgium	Clinique Saint-Joseph	Liege
Belgium	Regional Ziekenhuis Sint-Trudo	Sint-Truiden
Belgium	Sint-Andriesziekenhuis	Tielt
Belgium	Academisch Ziekenhuis Sint Augustinus	Wilrijk
Czech Republic	Fakultní nemocnice u sv. Anny v Brne	Brno
Czech Republic	Fakultní nemocnice Hradec Králové	Hradec Kralové
Czech Republic	Litomyšlská Nemocnice, a.s.	Litomyšl
Czech Republic	Fakultní nemocnice Olomouc	Olomouc
Czech Republic	Fakultní Nemocnice Ostrava	Ostrava
Czech Republic	Vítkovická nemocnice a.s.	Ostrava - Vítkovice
France	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
Germany	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
Germany	Asklepios Klinik Altona	Hamburg
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitätsklinikum Münster	Münster
Germany	Asklepios Fachklinikum Teupitz	Teupitz
Hungary	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	Gyor
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
Italy	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
Portugal	Hospital Garcia de Orta	Almada
Portugal	Hospitais da Universidade de Coimbra	Coimbra
Portugal	Hospital de Santa Maria	Lisboa
Portugal	Centro Hospitalar do Porto / Hospital Geral de Santo António	Porto
Portugal	Hospital de São João	Porto
Russian Federation	Municipal Healthcare Institution "Municipal Clinical Hospital # 3"	Chelyabinsk
Russian Federation	Regional Hospital #1, Ekaterinburg	Ekaterinburg
Russian Federation	Professor S.V. Ochapovsky Territorial Clinical Hospital #1	Krasnodar
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"	Moscow
Russian Federation	State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"	Petersburg Saint
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"	Samara
Russian Federation	Smolensk State Medical Academy of RosZdrav	Smolensk
Russian Federation	Bashkirian State Medical University	Ufa
Spain	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	Gerona
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
Sweden	Danderyds Sjukhus AB	Danderyd
Sweden	Sahlgrenska Universitetsjukhuset	Göteborg
Sweden	Universitetssjukhuset Linköping	Linköping
Sweden	Skånes Universitetssjukhus i Lund	Lund
Sweden	Mora lasarett	Mora
Sweden	Kärnsjukhuset i Skövde-KSS	Skövde
Switzerland	Universitätsspital Basel	Basel
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Klinik Hirslanden	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Portugal,  Russian Federation,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12		week 12	No
Secondary	Percentage of patients with NIHSS score less than or equal to 5 at Week 12		week 12	No
Secondary	Percentage of patients with at least one moderate to severe depressive		Baseline to week 12	No
Secondary	Change from baseline to Week 12 of the mean NIHSS total and motor scores		baseline to week 12	No
Secondary	Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests		baseline to week 12	No
Secondary	Percentage of patients with a mRS score less than or equal to 2 at Week 12		baseline to week 12	No