Ischemic StrokePhase 3LIFENCT01639014
Effect of F2695 on Functional Recovery After Ischemic Stroke
A Phase 3 study testing F2695 in people with Ischemic Stroke, run by Pierre Fabre Medicament at 87 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- F2695
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 532 participants
- Where
- 87 sitesin 11 countries
- Study dates
- Jul 2012to Feb 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
87 sites in 11 countries.
87 sites in 11 countries
Russia13 sites
Municipal Healthcare Institution "Municipal Clinical Hospital # 3"
Chelyabinsk
Professor S.V. Ochapovsky Territorial Clinical Hospital #1
Krasnodar
Clinical Hospital Number 31
Moscow
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
Moscow
Scientific Research Neurology Institute of Russian Academy of Medical Services
Moscow
State Budget Healthcare Institution "City clinical hospital #20"
Moscow
State Institution of Healthcare of Moscow City "City Clinical Hospital #61"
Moscow
State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"
Petersburg Saint
Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"
Samara
State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"
Samara
Smolensk State Medical Academy of RosZdrav
Smolensk
Bashkirian State Medical University
Ufa
Regional Hospital #1, Ekaterinburg
Yekaterinburg
Hungary11 sites
Jahn Ferenc Dél-pesti Kórház
Budapest
Magyar Honvédség Honvédkórház
Budapest
Semmelweis Egyetem Neurológiai Klinika
Budapest
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
Debrecen
Petz Aladár Megyei Oktató Kórház
Győr
Kaposi Mór Megyei Oktató Kórhaz
Kaposvár
BAZ Megyei és Egyetemi Oktató Kórház
Miskolc
Kanizsai Dorottya Kórház
Nagykanizsa
Jósa András Oktató Kórház
Nyíregyháza
Soproni Erzsébet Oktató Kórház
Sopron
Fejér Megyei Szent György Kórház
Székesfehérvár
Spain11 sites
Hospital General de Albacete
Albacete
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital Santa Creu i Sant Pau
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitario de Girona Doctor Josep Trueta
Girona
Hospital Clínico San Carlos
Madrid
Hospital Universitario La Princesa
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
Hospital de Tortosa Verge de la Cinta
Tortosa
Hospital Clinico Universitario de Valladolid
Valladolid
Germany10 sites
Neurologische Klinik GmbH
Bad Neustadt/Saale
Universitätsklinik Charité, Campus Mitte
Berlin
Universitätsklinikum Bonn
Bonn
Universitätsklinikum Erlangen
Erlangen
Universitätsklinikum Essen
Essen
Freiburger Universitätsklinik
Freiburg im Breisgau
Asklepios Klinik Altona
Hamburg
Universitätsklinikum Leipzig
Leipzig
Universitätsklinikum Münster
Münster
Asklepios Fachklinikum Teupitz
Teupitz
France9 sites
Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
Besançon
Clinique des Cèdres
Cornebarrieu
Centre Hospitalier de Lens
Lens
Hôpital Roger Salengro
Lille
Groupe Hospitalier Paris Saint Joseph
Paris
Hopital Lariboisière
Paris
Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
Poitiers
Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord
Saint-Priest-en-Jarez
Hôpital Purpan
Toulouse
Belgium7 sites
Cliniques Universitaires Saint Luc
Brussels
Universitair Ziekenhuis Gent
Ghent
Universitaire Ziekenhuis Gasthuisberg
Leuven
Clinique Saint-Joseph
Liège
Regional Ziekenhuis Sint-Trudo
Sint-Truiden
Sint-Andriesziekenhuis
Tielt
Academisch Ziekenhuis Sint Augustinus
Wilrijk
Czechia6 sites
Fakultní nemocnice u sv. Anny v Brne
Brno
Fakultní nemocnice Hradec Králové
Hradec Kralové
Litomyšlská Nemocnice, a.s.
Litomyšl
Fakultní nemocnice Olomouc
Olomouc
Fakultní Nemocnice Ostrava
Ostrava
Vítkovická nemocnice a.s.
Ostrava - Vítkovice
Italy6 sites
Azienda Sanitaria Ospedaliera "San Giovanni Battista"
Foligno
Azienda Ospedaliera San Gerardo
Monza
IRCCS "Istituto Neurologico C. Mondino"
Pavia
Ospedale Santa Maria della Misericordia
Perugia
IRCCS Fondazione Santa Lucia
Roma
Istituto Clinico Humanitas
Rozzano
Sweden6 sites
Danderyds Sjukhus AB
Danderyd
Sahlgrenska Universitetsjukhuset
Gothenburg
Universitetssjukhuset Linköping
Linköping
Skånes Universitetssjukhus i Lund
Lund
Mora lasarett
Mora
Kärnsjukhuset i Skövde-KSS
Skövde
Portugal5 sites
Hospital Garcia de Orta
Almada
Hospitais da Universidade de Coimbra
Coimbra
Hospital de Santa Maria
Lisbon
Centro Hospitalar do Porto / Hospital Geral de Santo António
Porto
Hospital de São João
Porto
Switzerland3 sites
Universitätsspital Basel
Basel
Centre Hospitalier Universitaire Vaudois
Lausanne
Klinik Hirslanden
Zurich
About this study
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
The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.
- Conditions
- Ischemic Stroke
- Being tested
- F2695, placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F2695Drug
75 mg OD in 2 capsules
placeboDrug
2 capsules
| Study group | Role | What they receive |
|---|---|---|
| F2695 | Experimental | Not described Receives: Drug: F2695 |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12
Measured: week 12
Secondary outcomes (5)
Percentage of patients with NIHSS score less than or equal to 5 at Week 12
Measured: week 12
Percentage of patients with at least one moderate to severe depressive
Measured: Baseline to week 12
Change from baseline to Week 12 of the mean NIHSS total and motor scores
Measured: baseline to week 12
Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests
Measured: baseline to week 12
Percentage of patients with a mRS score less than or equal to 2 at Week 12
Measured: baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- François Chollet, Principal investigator, Hôpital Purpan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639014
- Sponsor's protocol ID
- F02695 LP 2 05
- Other IDs
- 2012-001592-37
- Acronym
- LIFE
- Status last verified
- Mar 2014
- First submitted
- 10 Jul 2012
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01639014
- Acronym / sponsor ID
- LIFE / F02695 LP 2 05
- Conditions
- Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F2695 | Experimental | Drug: F2695 |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Aphasia
- Severe post-stroke condition
- Active depressive episode
- Intra-cerebral hemorrhage
- Use of anti-depressant drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F269575 mg OD in 2 capsules | Drug | F2695 |
| placebo2 capsules | Drug | placebo |
Primary outcome
Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12
Time frame: week 12
5 secondary outcomes
Percentage of patients with NIHSS score less than or equal to 5 at Week 12
Time frame: week 12
Percentage of patients with at least one moderate to severe depressive
Time frame: Baseline to week 12
Change from baseline to Week 12 of the mean NIHSS total and motor scores
Time frame: 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
Percentage of patients with a mRS score less than or equal to 2 at Week 12
Time frame: baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Chollet principal investigator
Hôpital Purpan
87 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing F2695 in people with Ischemic Stroke, run by Pierre Fabre Medicament at 87 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in Russia, Hungary, Spain, Germany, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12 (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.