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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
532

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hopital 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
        • Universitatsklinikum Bonn
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Essen, Germany
        • Universitätsklinikum Essen
      • Freiburg, Germany
        • Freiburger Universitätsklinik
      • Hamburg, Germany
        • Asklepios Klinik Altona
      • Leipzig, Germany
        • Universitatsklinikum 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 Aladár Megyei Oktató Kórház
      • 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 Clínico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pierre Fabre Medicament

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings