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    Summary
    EudraCT Number:2012-001592-37
    Sponsor's Protocol Code Number:F02695_LP_2_05
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2012-001592-37
    A.3Full title of the trial
    Effect of 3-month treatment with F2695 (75mg OD) on improving functional recovery of patients with ischemic stroke. A Multicenter, Randomised, Double-blind, Parallel-group, Placebo-Controlled Study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial is to assess the effect of 3-month treatment with F2695 on improving functional
    recovery after stroke. A study that will cover many study centres, and which will involve a random draw to decide whether placebo or active drug; neither the subject nor study doctor will know which of the two treatments are received.
    A.3.2Name or abbreviated title of the trial where available
    LIFE Study
    A.4.1Sponsor's protocol code numberF02695_LP_2_05
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPierre Fabre Médicament; Represented by Institut de Recherche Pierre Fabre
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPierre Fabre Médicament
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRPF – Pierre Fabre Innovation
    B.5.2Functional name of contact pointDr Mohammed ZAÏM
    B.5.3 Address:
    B.5.3.1Street AddressBP 13562 - 3 avenue Hubert Curien
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post codeF-3103
    B.5.3.4CountryFrance
    B.5.4Telephone number+33-(0)5-34-50-61-91
    B.5.5Fax number+33-(0)5-34-50-62-20
    B.5.6E-mailmohammed.zaim@pierre-fabre.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLevomilnacipran (hydrochloride)
    D.3.2Product code F2695
    D.3.4Pharmaceutical form Prolonged-release capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevomilnacipran
    D.3.9.2Current sponsor codeF2695
    D.3.9.3Other descriptive nameLevomilnacipran
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLevomilnacipran (hydrochloride)
    D.3.2Product code F2695
    D.3.4Pharmaceutical form Prolonged-release capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevomilnacipran
    D.3.9.2Current sponsor codeLevomilnacipran
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Functionnal impairment after acute ischemic stroke
    E.1.1.1Medical condition in easily understood language
    Handicap in post stroke patients
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of 3-month treatment with F2695 (75 mg OD) on improving functional recovery in patients with moderate to severe motor deficits after an ischemic stroke
    E.2.2Secondary objectives of the trial
    To assess the effect of F2695 on:
    o Motor recovery,
    o Occurrence and recurrence of depression,

    To evaluate the safety and tolerability of F2695 in patients with ischemic stroke.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Demographic Characteristics and Diagnostic criteria:
    To be included in the trial, patients admitted to stroke units should fulfil the following criteria:
    o Male or female patient, 18 to 80 years of age, inclusively,
    o Who had a confirmed acute ischemic stroke within the past 2 – 10 days , associated:
    o with an unilateral motor deficit (hemiparesis or hemiplegia),
    o with a National Institutes of Health stroke scale (NIHSS) motor score greater or equal to 5,
    o with a modified Rankin Scale (mRS) of 4 or 5,
    o Able and willing to comply with the site rehabilitation program requirements,
    o Woman of childbearing potential must have been using an effective method of contraception (defined as surgical or hormonal birth control, or intra-uterine device only), assessed by the investigator, for at least 2 months before selection in the study, and must accept to go on using it during the whole duration of the study and up to 1 month after the last dose of the study treatment, in order to avoid pregnancy while being exposed to the study treatment

    Ethical /legal considerations:
    o Signed written informed consent to take part in the study obtained from the patient. In case of impossibility for the patient to sign the consent form, the consent is to be witnessed by a third party completely independent from the investigator and the sponsor. This witness will have to sign the consent form and the patient will have to sign the consent form once his condition permits , before the end of the study.
    o Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).
    E.4Principal exclusion criteria
    - Disease-related criteria:
    o Patient with motor sequelae from a previous stroke,
    o Patient with pre-existing or concomitant deficit that could interfere with testing or clinical assessments,
    o Patient with aphasia preventing correct evaluation of motor and / or depression scales,
    o Patient with severe post-stroke condition (NIHSS score >20),
    o Patient with active depressive episode (MADRS score of more than 18 and / or a Clinical Global Impression scale in depression – CGI - Depression > 3),
    o Patient with evidence of intra-cerebral haemorrhage on brain MRI or CT scan,
    o Patient needing carotid surgery within 3 months.

    - Previous or concomitant treatment-related criteria:
    o Patient having taken within the month preceding inclusion one or more of the following drugs:
    o antidepressant drugs belonging to the classes of SSRIs, SNRIs and TCAs (whatever the indication),
    o monoamine oxidase inhibitors or any other drug which may increase the risk of serotonin syndrome (tramadol, methylphenidate, triptans, propoxyphene, lithium…) except tramadol (or related opiod analgesics) and triptans drugs for which the wash-out is 72 hours before the first intake of study treatment,
    o neuroleptic drugs, except the antiemetic drugs for which the wash-out is 48 hours before the first intake of study treatment
    o alpha1-adrenoreceptor antagonists, except the intravenous antihypertensive drugs for which the wash-out is 24 hours before the first intake of study treatment
    o central nervous system stimulants (modafinil, methylphenidate, amphetamines…),
    o Patient with an history of intolerance or hypersensitivity to F2695, milnacipran or other SNRIs, SSRIs, or selective noradrenergic reuptake inhibitors,
    o Patient displaying criteria for psychoactive substance abuse or dependency (according to DSM-IV).

    - Patient-related criteria:
    o Patient with severe cognitive impairment or dementia,
    o Patient presents an acute coronary syndrome,
    o Patient presenting cardiac rhythm disorder (including
    tachyarrhythmia) in the 3 months preceding the inclusion,
    o Patient presenting uncontrolled arterial hypertension or symptomatic postural hypotension,
    o Patient with history of myocardial infarction in the preceding 3 months,
    o Patient unable to safely swallow capsules,
    o Patient presenting disability (mRS > 1) prior to the current stroke (rheumatological diseases, sequelaes of traumatic diseases or from previous stroke injury…),
    o Patient with the following abnormal clinical laboratory test results:
    - Liver function test values (aspartate aminotransferase and/or alanine aminotransferase) greater than 3 times the upper limit of normal,
    - An estimated glomerular filtration rate (eGFR) < 60ml/min/1,73m2
    o Patient with a history of coagulation or haemostasis disorders which the investigator deems incompatible with study implementation,
    o Patient with a history of narrow angle glaucoma,
    o Patients with a prior history of seizures/epilepsy (before the onset of stroke event),
    o Patient presenting with a severe acute or chronic disease which the investigator deems incompatible with study implementation. This includes evidence of malignancy or any significant or progressive disease (endocrine, respiratory, renal, hepatic, gastrointestinal, neurologic disease or infectious disease),
    o Patient liable not to comply with protocol instructions and/or with treatment (including rehabilitation therapy), in the investigator's opinion,
    o Male patients with history of obstructive voiding symptoms, including urinary retention,
    o For women patients:
    - pregnant, breast feeding or likely to become pregnant during the time of the study
    o women with childbearing potential not using effective contraception (defined as surgical or hormonal birth control, or intra-uterine device only).
    o positive serum β-hCG pregnancy test at inclusion for females with childbearing potential.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy end-point is the primary criterion will be the response rate defined as the percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficay end point will be measure at Week 12
    E.5.2Secondary end point(s)
    Secondary efficacy criteria include:
    1) A mRS score less than or equal to 2 at Week 12
    2) The change from baseline to Week 12 of the:
    - mRS score,
    - mean NIHSS total and motor scores,
    3) The percentage of patients with :
    - an NIHSS score less than or equal to 5 at Week 12,
    - at least one moderate to severe depressive episode (MADRS > 25 and or CGI-depression > 4) at Week 12.

    Safety end-points:
    1) percentage of patients reporting at least one adverse event (AE) in each group,
    2) physical examination, vital sign measurements
    3) electrocardiograms (ECGs),
    4) clinical laboratory values.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary efficacy endpoints will be measured at Week 12.

    The safety end points will be measured at each visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Netherlands
    Portugal
    Russian Federation
    Spain
    Sweden
    Switzerland
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of last patient as per protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 133
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 399
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 470
    F.4.2.2In the whole clinical trial 532
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard care for stroke
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-11
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