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    Summary
    EudraCT Number:2020-000439-32
    Sponsor's Protocol Code Number:NW-3509/015/II/2019
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-21
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000439-32
    A.3Full title of the trial
    An open-label, multi-center, extension study to evaluate the long-term safety, tolerability and preliminary efficacy of Evenamide as add-on treatment in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication.
    Studio di estensione in aperto, multicentrico per valutare sicurezza, tollerabilità ed efficacia preliminare a lungo termine di evenamide come terapia aggiuntiva in pazienti affetti da schizofrenia resistente al trattamento (TRS) che non rispondono adeguatamente al farmaco antipsicotico attualmente in corso
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, multi-center, extension study to evaluate the long-term safety, tolerability and preliminary efficacy of Evenamide as add-on treatment in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication.
    Studio di estensione in aperto, multicentrico per valutare sicurezza, tollerabilità ed efficacia preliminare a lungo termine di evenamide come terapia aggiuntiva in pazienti affetti da schizofrenia resistente al trattamento (TRS) che non rispondono adeguatamente al farmaco antipsicotico attualmente in corso
    A.3.2Name or abbreviated title of the trial where available
    NW-3509/015/II/2019
    NW-3509/015/II/2019
    A.4.1Sponsor's protocol code numberNW-3509/015/II/2019
    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 SponsorNEWRON PHARMACEUTICALS SPA
    B.1.3.4CountryItaly
    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 organisationPharmaceutical Development and services S.r.l.
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia dei Pratoni 16
    B.5.3.2Town/ cityScandicci
    B.5.3.3Post code50018
    B.5.3.4CountryItaly
    B.5.4Telephone number0557224179
    B.5.5Fax number0557227014
    B.5.6E-mailedimartino@pharmades.it
    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 nameEvenamide
    D.3.2Product code [NW-3509]
    D.3.4Pharmaceutical form 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.3.9.1CAS number 1092977-61-1
    D.3.9.2Current sponsor codeNW-3509
    D.3.9.4EV Substance CodePRD7161317
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 nameEvenamide
    D.3.2Product code [NE-3509]
    D.3.4Pharmaceutical form 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.3.9.1CAS number 1092977-61-1
    D.3.9.2Current sponsor codeNW-3509
    D.3.9.4EV Substance CodePRD7161318
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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: 3
    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 nameEvenamide
    D.3.2Product code [NW-3509]
    D.3.4Pharmaceutical form 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.3.9.1CAS number 1092977-61-1
    D.3.9.2Current sponsor codeNW-3509
    D.3.9.4EV Substance CodePRD7161319
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schizophrenia not responding adequately to current antipsychotic treatment
    Schizofrenia resistente al trattamento con una dose terapeutica stabile di un farmaco antipsicotico
    E.1.1.1Medical condition in easily understood language
    Treatment-resistant schizophrenia (TRS)
    Schizofrenia trattamento-resistente (TRS)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10072913
    E.1.2Term Treatment-resistant schizophrenia
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and tolerability of evenamide given orally in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication.
    Valutare sicurezza e tollerabilità a lungo termine di evenamide somministrata per via orale in soggetti affetti da schizofrenia resistente al trattamento che non rispondono adeguatamente al corrente farmaco antipsicotico assunto.
    E.2.2Secondary objectives of the trial
    To evaluate preliminary long-term efficacy of evenamide, based on symptoms of schizophrenia, as assessed by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression - Change from baseline (CGI-C) and Severity of illness (CGI-S); to determine the long-term effect of evenamide on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale.
    Valutare l'efficacia preliminare a lungo termine di evenamide, in base ai sintomi della schizofrenia, valutata mediante la Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression - Change from baseline (CGI-C) e Severity of illness (CGI-S); determinare l'effetto a lungo termine di evenamide sulla Scala del livello funzionale, in base al cambiamento del punteggio sulla scala LOF (Strauss-Carpenter Level of Functioning Scale).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet the following inclusion criteria to be eligible for enrollment into the study:
    1. Patient completed 6 weeks of treatment in Study 014.
    2. Patient has provided written informed consent for this extension study.
    3. If female, patient is not of childbearing potential, pregnant or breastfeeding. For inclusion, female patients must be post-menopausal (age 50 or older with confirmed amenorrhea for >12 months), surgically sterilized, or protected with adequate contraception (barrier method or hormonal contraceptive).
    Per essere eleggibile per l'arruolamento nello studio, un paziente deve soddisfare tutti i seguenti criteri di inclusione:
    1. Aver completato le 6 settimane di trattamento dello studio 014.
    2. Fornire il consenso informato scritto per questo studio di estensione.
    3. Se di sesso femminile, le pazienti non devono essere in età fertile, in gravidanza o in allattamento. Per poter essere incluse, le pazienti di sesso femminile devono essere in post-menopausa (età pari a 50 anni o più con amenorrea confermata per > 12 mesi), sterilizzate chirurgicamente o utilizzare un metodo contraccettivo adeguato (metodo di barriera o contraccettivo ormonale) e seguire le istruzioni del medico curante.
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a patient from study enrollment:
    1. Patient violated any requirement of the protocol in Study 014 that would put him/her at risk for continuing treatment with evenamide in Study 015.
    2. In the Investigator’s opinion, the patient had a significant worsening of risk for suicidality during Study 014.
    3. Patient is experiencing any moderate/severe neurological side effects, other than pre-existing EPS related to antipsychotic treatment prior to enrolling in Study 014.
    4. Patient has shown significant worsening of his/her symptoms of schizophrenia between baseline and the final assessment during the 6-week treatment period in Study 014, such that continuing treatment in Study 015 is considered undesirable.
    5. Patient demonstrated substantial non-compliance with dosing of the study medication in Study 014.
    La presenza di uno qualsiasi dei seguenti criteri porterà all’esclusione di un soggetto dello studio:
    1. Il soggetto ha violato uno qualsiasi dei requisiti del protocollo dello studio 014 che lo porrebbe a rischio per il proseguimento del trattamento con evenamide nello studio 015.
    2. Secondo lo sperimentatore, il soggetto ha avuto un significativo peggioramento del rischio di suicidio nel corso dello studio 014.
    3. Il soggetto manifesta effetti collaterali neurologici moderati o gravi, diversi da sintomi extrapiramidali preesistenti e correlati alla terapia con farmaci antipsicotici assunti prima dell’ingresso nello Studio 014.
    4. Il soggetto ha mostrato un peggioramento significativo dei sintomi della schizofrenia tra l’inizio dello studio e la valutazione finale durante il periodo di trattamento di 6 settimane dello Studio 014, in modo tale da ritenere che la prosecuzione del trattamento nello Studio 015 sia sconsigliata.
    5. Il soggetto ha mostrato una sostanziale mancanza di aderenza nel trattamento con il farmaco di studio nel corso dello Studio 014.
    E.5 End points
    E.5.1Primary end point(s)
    Safety will be assessed by the following:
    • Adverse events (AEs)
    • Vital signs (systolic/diastolic blood pressure, pulse, body temperature, respiratory rate, body weight, BMI, waist circumference)
    • Laboratory evaluations (hematology, blood chemistry, and urinalysis; serum prolactin).
    • Electrocardiogram (ECG) – 12-lead standard
    • Physical examination
    • Neurological examination
    • Standard eye examination – visual acuity (Snellen chart), visual field, eye muscles, pupillary response, fundus (dilated, if feasible), tonometry, and front part of eyes (eyelids, cornea, conjunctiva, sclera and iris)
    • Extrapyramidal Symptom Rating Scale - Abbreviated version (ESRS-A)
    • Calgary Depression Scale for Schizophrenia (CDSS).
    Valutazioni di sicurezza - Obiettivo di sicurezza primario
    La sicurezza verrà valutata in base a quanto segue:
    • Eventi avversi (AEs)
    • Segni vitali (pressione arteriosa sistolica / diastolica, pulsazioni, temperatura corporea, frequenza respiratoria, peso corporeo, indice di massa corporea, circonferenza addominale)
    • Valutazioni di laboratorio (ematologia, ematochimica e analisi delle urine; prolattina sierica).
    • Elettrocardiogramma (ECG) - standard a 12 derivazioni
    • Esame obiettivo
    • Esame neurologico
    • Esame oculistico standard: acuità visiva (tabella di Snellen), campo visivo, muscoli oculari, risposta pupillare, fondo (con pupille dilatate, se possibile), tonometria e parte anteriore degli occhi (palpebre, cornea, congiuntiva, sclera e iride)
    • Extrapyramidal Symptom Rating Scale - Versione abbreviata (ESRS-A)
    • Scala CDSS (Calgary Depression Scale for Schizophrenia).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and efficacy evaluations will be performed at Weeks 6, 12, 18, 24 and 36 during scheduled visits at the clinic, and at weeks 30 and 41 during telephone contacts.
    Le valutazioni finali di sicurezza e efficaci verranno effettuate alle visite alla settimana 6, 12, 18, 24, 36 e 46 in occasione del ritorno dei pazienti al centro e alla settimana 30 e 41 in occasione di contatti telefonici da parte dello staff del centro.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    in aperto con valutatore in cieco
    open-label with blind evaluator
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    India
    Malaysia
    Sri Lanka
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 143
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 150
    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)
    NA
    NA
    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 Decision2020-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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