Functionnal impairment after acute ischemic stroke MedDRA version: 14.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Levomilnacipran (hydrochloride)
Product Code: F2695
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: Levomilnacipran
Current Sponsor code: F2695
Other descriptiv
Sponsors
Pierre Fabre Médicament; Represented by Institut de Recherche Pierre Fabre
Eligibility
Sex/Gender
All
Inclusion criteria
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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 133 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 399
Exclusion criteria
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...) o neuroleptic drugs, o alpha1-adrenoreceptor antagonists, 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 ?-hCG pregnancy test at inclusion for females with childbearing po
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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.;Primary 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 2 at Week 12.;Timepoint(s) of evaluation of this end point: The primary efficay end point will be measure at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy criteria include: 1) The change from baseline to Week 12 of the: - mRS score, - mean NIHSS total and motor scores, 2) 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.;Timepoint(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 | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Portugal, Russian Federation, Spain, Sweden, Switzerland
Contacts
Public ContactDr Mohammed ZAÏM
IRPF - Pierre Fabre Innovation
Outcome results
None listed