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    Summary
    EudraCT Number:2009-010642-57
    Sponsor's Protocol Code Number:IC4-20098-542
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-03
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2009-010642-57
    A.3Full title of the trial
    “Efficacy and safety of ValdoxanR given orally once a day for 24 weeks in patients with Major Depressive Disorder.” Open, national, multicentric clinical trial for the evaluation of the antidepressant efficacy and tolerability of ValdoxanR and its additional clinical benefits for depressed patients.
    A.4.1Sponsor's protocol code numberIC4-20098-542
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorServier Slovensko, spol. s.r.o.
    B.1.3.4CountrySlovakia
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name VALDOXAN
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameS20098
    D.3.2Product code S20098
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNagomelatine
    D.3.9.1CAS number 138112-76-2
    D.3.9.2Current sponsor codeS20098
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11.1
    E.1.2Level LLT
    E.1.2Classification code 10057840
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this open study is to assess the efficacy of ValdoxanR in depressed patients. Montgomery-Åsberg Depression Rating Scale (MADRS) will be used for efficacy assessment. An 8-week treatment period in patients suffering from major depressive disorder will be evaluated. This evaluation will be made in the whole population and in sub-groups of patients receiving ValdoxanR in monotherapy or co-prescription of anxiolytics and/or hypnotics.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate efficacy of ValdoxanR on clinician-rated scales - namely the Clinical Global Impression (CGI) and Global Assessment of Functioning (GAF) scales.
    Another objective, set up during preparation of this trial, is to evaluate the impact of ValdoxanR on patients’ sleep and daytime functioning from the patient’s point of view. Screening of Sleep and Circadian Rhythms Disorders questionnaire (Circscreen) and the Sheehan Disability questionnaire scales will be used.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Demographic characteristics
    - Aged 18 to 65 years (inclusive)
    - Male or female
    - Outpatients
    Diagnosis criteria - According to clinical examination in the phase of choice of the patients are verified following conditions:
    - Clinical diagnosis of depressive disorder verified according to MINI criteria (Mini International Neuropsychiatric Interview). Present episode can have moderate or serious intensity, with or without symptoms of melancholic subtype of depressive episode, without psychotic symptoms and the beginning of episode can not correlate with postpartum period.
    - MADRS score at least 20
    - State, which demands the therapy with antidepressants
    - Patient is not treated with antidepressants at the time of involvement in the study
    E.4Principal exclusion criteria
    General criteria
    - Patients, which do not want to cooperate adequately or the patients in whom we can not expect sufficient compliance during the therapeutic period
    - Patients, which will not be available for examinations like it is defined in protocol (for example holidays, ...)
    • Pregnant or breastfeeding women
    • Women, which can potentially get pregnant and the adequate contraception is not provided (per oral contraception, intrauterine device or using of condoms)
    • Involvement in other study at he same time or in the period of three months before involvement in study, or it is known, that the patient is involved in another study at the time of choice of patients

    Medical and therapeutic criteria
    • Related to depression
    - All types of depression other than major depressive disorder, including Bipolar Disorder I and II, Double Depression (MDD combined with Dysthymic Disorder), chronic depressive disorder (defined as an episode of depression with a duration longer than 2 years), Schizoaffective Disorder of the depressive type, depression with psychotic features.
    - Dysthymic Disorder according to DSM IV criteria.
    - Current depressive episode having not responded to two different previous antidepressant treatments given for at least 4 weeks at an appropriate dose.
    - Marked suicidal intent and/or known suicidal tendencies for the current episode, based on item 10 of MADRS along with the investigator's opinion based on the patient’s medical history, previous suicide attempts, and quality of social and familial support.
    - Patient treated with electroconvulsive therapy within the last 3 months before inclusion or requiring electroconvulsive therapy at present (according to investigator’s judgment).
    - Insight-oriented and structured psychotherapy (interpersonal therapy, psychoanalysis, cognitive behavioral therapy) started within the 3 months before inclusion.
    - Light therapy received within 2 weeks before inclusion.
    • Related to other psychiatric conditions
    - Patients meeting DSM-IV diagnosis of current Panic Disorder, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, acute Stress Disorder.
    - Patients with acute or chronic psychotic disorder.
    - Patients with antisocial, borderline, or histrionic personality disorders according to DSM IV criteria.
    - Patients with a severe personality disorder other than antisocial, borderline, or histrionic and prone to interfering with the evaluation of the study according to the investigator’s judgment.
    • Related to miscellaneous conditions
    - Alcohol or drug abuse or dependence within the past 12 months (excluding nicotine), as defined in DSM-IV.
    - Hepatic impairment. (i.e. cirrhosis or active liver disease)
    - ASAT, ALAT values > 2 times the upper reference value
    - Delirium or dementia according to DSM-IV.
    - Current diagnosis of neurological disorders: eg, stroke, seizures, migraine …
    - Severe or uncontrolled organic disease likely to interfere with the conduct of the study (eg, neoplastic, cardiovascular, pulmonary and digestive disorders, unstabilized diabetes of type I or II, untreated or uncontrolled arterial hypertension).
    - acute porphyria.
    - Shift workers.

    • Conditions related to previous or present therapy - All treatment listed below should be stopped before the inclusion in the study with respect of the corresponding wash-out period:
    - Antipsychotic drugs (including depot antipsychotic drugs, if they were administrated less then 2 months before involvement in study)
    - Thymoprophylactics – lithium salts, antiepileptics
    - Therapy with other antidepressants (except of fluoxetine) three days or less before involvement in the study
    - Therapy with fluoxetine 14 days or less before involvement in the study
    - Therapy with anxiolytics and/or hypnotics - benzodiazepine or non-benzodiazepine type, if there is no assumption, that it will be possible to finish therapy within 14 days before involvement in the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this open study is to assess the efficacy of ValdoxanR in depressed patients. Montgomery-Åsberg Depression Rating Scale (MADRS) will be used for efficacy assessment. An 8-week treatment period in patients suffering from major depressive disorder will be evaluated. This evaluation will be made in the whole population and in sub-groups of patients receiving ValdoxanR in monotherapy or co-prescription of anxiolytics and/or hypnotics.
    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 Yes
    E.6.13Others Information not present in EudraCT
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned16
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state160
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 160
    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 Decision2009-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-01
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