LIFE: Effect of F2695 on Functional Recovery After Ischemic Stroke
Sponsor
Pierre Fabre Medicament (Industry)
Overall Status
Completed
CT.gov ID
NCT01639014
Collaborator
(none)
532
87
2
31
6.1
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
532 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date
:
Jul 1, 2012
Actual Primary Completion Date
:
Feb 1, 2015
Actual Study Completion Date
:
Feb 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: F2695
|
Drug: F2695
75 mg OD in 2 capsules
|
| Placebo Comparator: placebo
|
Drug: placebo
2 capsules
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12 [week 12]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cliniques Universitaires Saint Luc | Brussels | Belgium | ||
| 2 | Universitair Ziekenhuis Gent | Ghent | Belgium | ||
| 3 | Universitaire Ziekenhuis Gasthuisberg | Leuven | Belgium | ||
| 4 | Clinique Saint-Joseph | Liege | Belgium | ||
| 5 | Regional Ziekenhuis Sint-Trudo | Sint-Truiden | Belgium | ||
| 6 | Sint-Andriesziekenhuis | Tielt | Belgium | ||
| 7 | Academisch Ziekenhuis Sint Augustinus | Wilrijk | Belgium | ||
| 8 | Fakultní nemocnice u sv. Anny v Brne | Brno | Czech Republic | ||
| 9 | Fakultní nemocnice Hradec Králové | Hradec Kralové | Czech Republic | ||
| 10 | Litomyšlská Nemocnice, a.s. | Litomyšl | Czech Republic | ||
| 11 | Fakultní nemocnice Olomouc | Olomouc | Czech Republic | ||
| 12 | Vítkovická nemocnice a.s. | Ostrava - Vítkovice | Czech Republic | ||
| 13 | Fakultní Nemocnice Ostrava | Ostrava | Czech Republic | ||
| 14 | Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon | Besançon | France | ||
| 15 | Clinique des Cèdres | Cornebarrieu | France | ||
| 16 | Centre Hospitalier de Lens | Lens | France | ||
| 17 | Hôpital Roger Salengro | Lille | France | ||
| 18 | Groupe Hospitalier Paris Saint Joseph | Paris | France | ||
| 19 | Hopital Lariboisière | Paris | France | ||
| 20 | Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie | Poitiers | France | ||
| 21 | Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord | Saint Priest en Jarez | France | ||
| 22 | Hôpital Purpan | Toulouse | France | ||
| 23 | Neurologische Klinik GmbH | Bad Neustadt/Saale | Germany | ||
| 24 | Universitätsklinik Charité, Campus Mitte | Berlin | Germany | ||
| 25 | Universitätsklinikum Bonn | Bonn | Germany | ||
| 26 | Universitätsklinikum Erlangen | Erlangen | Germany | ||
| 27 | Universitätsklinikum Essen | Essen | Germany | ||
| 28 | Freiburger Universitätsklinik | Freiburg | Germany | ||
| 29 | Asklepios Klinik Altona | Hamburg | Germany | ||
| 30 | Universitätsklinikum Leipzig | Leipzig | Germany | ||
| 31 | Universitätsklinikum Münster | Münster | Germany | ||
| 32 | Asklepios Fachklinikum Teupitz | Teupitz | Germany | ||
| 33 | Jahn Ferenc Dél-pesti Kórház | Budapest | Hungary | ||
| 34 | Magyar Honvédség Honvédkórház | Budapest | Hungary | ||
| 35 | Semmelweis Egyetem Neurológiai Klinika | Budapest | Hungary | ||
| 36 | Debreceni Egyetem Orvos- és Egészségtudományi Centrum | Debrecen | Hungary | ||
| 37 | Petz Aladár Megyei Oktató Kórház | Gyor | Hungary | ||
| 38 | Kaposi Mór Megyei Oktató Kórhaz | Kaposvár | Hungary | ||
| 39 | BAZ Megyei és Egyetemi Oktató Kórház | Miskolc | Hungary | ||
| 40 | Kanizsai Dorottya Kórház | Nagykanizsa | Hungary | ||
| 41 | Jósa András Oktató Kórház | Nyíregyháza | Hungary | ||
| 42 | Soproni Erzsébet Oktató Kórház | Sopron | Hungary | ||
| 43 | Fejér Megyei Szent György Kórház | Székesfehérvár | Hungary | ||
| 44 | Azienda Sanitaria Ospedaliera "San Giovanni Battista" | Foligno | Italy | ||
| 45 | Azienda Ospedaliera San Gerardo | Monza | Italy | ||
| 46 | IRCCS "Istituto Neurologico C. Mondino" | Pavia | Italy | ||
| 47 | Ospedale Santa Maria della Misericordia | Perugia | Italy | ||
| 48 | IRCCS Fondazione Santa Lucia | Roma | Italy | ||
| 49 | Istituto Clinico Humanitas | Rozzano | Italy | ||
| 50 | Hospital Garcia de Orta | Almada | Portugal | ||
| 51 | Hospitais da Universidade de Coimbra | Coimbra | Portugal | ||
| 52 | Hospital de Santa Maria | Lisboa | Portugal | ||
| 53 | Centro Hospitalar do Porto / Hospital Geral de Santo António | Porto | Portugal | ||
| 54 | Hospital de São João | Porto | Portugal | ||
| 55 | Municipal Healthcare Institution "Municipal Clinical Hospital # 3" | Chelyabinsk | Russian Federation | ||
| 56 | Regional Hospital #1, Ekaterinburg | Ekaterinburg | Russian Federation | ||
| 57 | Professor S.V. Ochapovsky Territorial Clinical Hospital #1 | Krasnodar | Russian Federation | ||
| 58 | Clinical Hospital Number 31 | Moscow | Russian Federation | ||
| 59 | Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway | Moscow | Russian Federation | ||
| 60 | Scientific Research Neurology Institute of Russian Academy of Medical Services | Moscow | Russian Federation | ||
| 61 | State Budget Healthcare Institution "City clinical hospital #20" | Moscow | Russian Federation | ||
| 62 | State Institution of Healthcare of Moscow City "City Clinical Hospital #61" | Moscow | Russian Federation | ||
| 63 | State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency" | Petersburg Saint | Russian Federation | ||
| 64 | Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1" | Samara | Russian Federation | ||
| 65 | State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital" | Samara | Russian Federation | ||
| 66 | Smolensk State Medical Academy of RosZdrav | Smolensk | Russian Federation | ||
| 67 | Bashkirian State Medical University | Ufa | Russian Federation | ||
| 68 | Hospital General de Albacete | Albacete | Spain | ||
| 69 | Hospital Universitari Germans Trias i Pujol | Badalona | Spain | ||
| 70 | Hospital Santa Creu i Sant Pau | Barcelona | Spain | ||
| 71 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | ||
| 72 | Hospital Universitario de Girona Doctor Josep Trueta | Gerona | Spain | ||
| 73 | Hospital Clínico San Carlos | Madrid | Spain | ||
| 74 | Hospital Universitario La Princesa | Madrid | Spain | ||
| 75 | Hospital Universitario Ramón y Cajal | Madrid | Spain | ||
| 76 | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | Spain | ||
| 77 | Hospital de Tortosa Verge de la Cinta | Tortosa | Spain | ||
| 78 | Hospital Clinico Universitario de Valladolid | Valladolid | Spain | ||
| 79 | Danderyds Sjukhus AB | Danderyd | Sweden | ||
| 80 | Sahlgrenska Universitetsjukhuset | Göteborg | Sweden | ||
| 81 | Universitetssjukhuset Linköping | Linköping | Sweden | ||
| 82 | Skånes Universitetssjukhus i Lund | Lund | Sweden | ||
| 83 | Mora lasarett | Mora | Sweden | ||
| 84 | Kärnsjukhuset i Skövde-KSS | Skövde | Sweden | ||
| 85 | Universitätsspital Basel | Basel | Switzerland | ||
| 86 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | ||
| 87 | Klinik Hirslanden | Zürich | Switzerland |
Sponsors and Collaborators
- Pierre Fabre Medicament
Investigators
- Principal Investigator: François Chollet, Hôpital Purpan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01639014
Other Study ID Numbers:
- F02695 LP 2 05
- 2012-001592-37
First Posted:
Jul 12, 2012
Last Update Posted:
Apr 1, 2015
Last Verified:
Mar 1, 2014