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    Summary
    EudraCT Number:2020-000437-41
    Sponsor's Protocol Code Number:NW-3509/014/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 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000437-41
    A.3Full title of the trial
    A pilot, open-label, rater-blinded, randomized, parallel-group, multi-center study to evaluate the safety, tolerability and preliminary efficacy of three add-on fixed doses of Evenamide in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their stable, therapeutically active dose of a single antipsychotic medication
    Studio multicentrico pilota, in aperto, con valutatore in cieco (rater-blinded), randomizzato, a gruppi paralleli per valutare sicurezza, tollerabilità ed efficacia preliminare di tre dosi fisse di Evenamide somministrate come terapia aggiuntiva a pazienti affetti da schizofrenia resistente al trattamento (TRS) che non rispondono adeguatamente al farmaco antipsicotico attualmente in corso a dosi terapeutiche stabili.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot, open-label, rater-blinded, randomized, parallel-group, multi-center study to evaluate the safety, tolerability and preliminary efficacy of three add-on fixed doses of Evenamide in patients with treatment-resistant schizophrenia (TRS).
    Studio multicentrico pilota, in aperto, randomizzato, per valutare sicurezza, tollerabilità ed efficacia preliminare in tre gruppi paralleli con tre dosi fisse di Evenamide somministrate come terapia aggiuntiva a pazienti affetti da schizofrenia resistente al trattamento (TRS).
    A.3.2Name or abbreviated title of the trial where available
    NW-3509/014/II/2019
    NW-3509/014/II/2019
    A.4.1Sponsor's protocol code numberNW-3509/014/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
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia dei Pratoni 16
    B.5.3.2Town/ cityFirenze
    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 [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 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.3.9.2Current 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 safety and tolerability of evenamide given orally at three fixed doses (7.5, 15 and 30 mg bid) in patients with treatment-resistant schizophrenia not responding adequately to a stable, therapeutic doses of their current antipsychotic medication.
    Valutare sicurezza e tollerabilità di evenamide somministrata per via orale a tre dosi fisse (7,5, 15 e 30 mg bid) in pazienti affetti da schizofrenia resistente al trattamento che non rispondono adeguatamente a dosi terapeutiche stabili dei loro attuali farmaci antipsicotici.
    E.2.2Secondary objectives of the trial
    To evaluate preliminary efficacy of the three fixed doses 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 effect of evenamide on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale.
    Valutare l'efficacia preliminare delle tre dosi fisse di evenamide, in base ai sintomi della schizofrenia, valutata mediante la variazione dal basale della Positive and Negative Syndrome Scale (PANSS) e la Clinical Global Impression - Change from baseline (CGI-C) e Severity of Illness (CGI -S);
    Determinare l'effetto di evenamide sulla Scala del livello funzionale, in base al cambiamento del punteggio sulla scala LOF (Strauss-Carpenter Level of Functioning).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age - 18 years, or older.
    2. Sex – male, or female not of childbearing potential, unless using adequate
    contraception, as determined by their Health Care Provider.
    3. Meets current DSM-5 criteria for schizophrenia. Other psychiatric disorders may be
    present only as lifetime diagnoses if they are not relevant to the current episode of
    schizophrenia. [see Exclusion criteria below]
    4. Has been diagnosed with schizophrenia within the past 10 years.
    5. Has shown treatment-resistance according to psychiatric history, with the last failed
    treatment documented in the patient’s clinical records. “Treatment-resistant
    Schizophrenia” (TRS) is defined as a persistence of significant clinical symptoms
    despite adequate doses of two standard antipsychotic medications (other than clozapine)
    from two different chemical classes, including at least one atypical antipsychotic, for
    at least 6 weeks of treatment each. The last failed treatment trial must be documented.
    6. Has a Clinical Global Impression – Severity of disease (CGI-S) rating of moderately
    ill to severely ill (score of 4 to 6 [scale 1-7]).
    7. Has a PANSS total score = 70 at screening and baseline.
    8. Has a score of 4 (moderate) or more on at least 2 of the following 4 PANSS symptoms
    of psychosis: P2 (Conceptual Disorganization), P3 (Hallucinatory Behavior), P6
    (Suspiciousness/Persecution) and G9 (Unusual Thought Content); and a total score of at
    least 20 on the combined total of the PANSS symptom items: P1 (Delusions), P2
    (Conceptual Disorganization), P3 (Hallucinatory Behavior), P4 (Excitement), P6
    (Suspiciousness/Persecution), P7 (Hostility), and G9 (Unusual thought content).
    9. Has a Global Assessment of Functioning (GAF) scale total score = 50.
    10. Is in need of anti-psychotic treatment and is currently receiving mono-therapy at a
    stable dose (minimally for 4 weeks prior to screening) at a minimal recommended
    therapeutic or higher dose of one antipsychotic (atypical or typical, other than
    clozapine). Current use of quetiapine at a dose of 150 mg or less at night as a
    soporific will not be considered polypharmacy.
    11. Current level of symptoms has been present for at least one month, but not exceeding
    one year.
    12. Patient is cooperative, able to take oral medication, able to understand the
    instructions and willing to complete all aspects of the study, and is capable of doing
    so.
    13. Patient is residing with a caregiver at his/her home, or is either in a residential
    care facility or residing alone, with a caregiver available to help ensure compliance
    with dosing and scheduled office visits in either situation.
    14. Patient has provided written informed consent prior to participating in the study.
    15. Patient agrees to be hospitalized overnight if required for trial purposes or if the investigator deems it necessary to ensure the safety of the patient.
    1. Età pari so superiore a 18 anni.
    2. Sesso - uomo o donna non in età fertile, a meno che non utilizzi un contraccettivo
    adeguato come determinato dal fornitore di assistenza sanitaria.
    3. Diagnosi attuale di schizofrenia ai sensi del DSM-5 con soddisfacimento di tutti i
    criteri. Altri disturbi psichiatrici possono essere presenti solo come diagnosi a vita
    se non sono rilevanti per il corrente episodio di schizofrenia (vedere i criteri di
    esclusione di seguito).
    4. Ha ricevuto la diagnosi di schizofrenia negli ultimi 10 anni.
    5. Ha mostrato resistenza al trattamento della schizofrenia secondo l'anamnesi
    psichiatrica. L'ultimo episodio di resistenza deve essere documentato nella cartella
    clinica del paziente. La "schizofrenia resistente al trattamento" (TRS) è definita come
    una persistenza di sintomi clinici significativi nonostante vengano assunte dosi
    adeguate di due farmaci antipsicotici standard (diversi dalla clozapina) appartenenti a
    due diverse classi chimiche, tra cui almeno un antipsicotico atipico, per almeno 6
    settimane di trattamento ciascuno. L'ultimo fallimento terapeutico dev'essere
    documentato.
    6. Valutazione dell'impressione clinica globale - gravità della malattia (CGI-S) da
    moderata a grave (punteggio di 4-6 [scala 1-7]).
    7. Punteggio totale sulla PANSS = 70 allo screening e al basale.
    8. Punteggio di 4 (moderato) o superiore su almeno 2 dei seguenti 4 sintomi di psicosi
    sulla PANSS: P2 (Disorganizzazione concettuale), P3 (Allucinazioni), P6
    (Sospettosità/Persecuzione) e G9 (Contenuto di pensiero insolito) ; e punteggio totale
    di almeno 20 sul totale degli elementi dei seguenti sintomi sulla PANSS: P1 (delirio),
    P2 (disorganizzazione concettuale), P3 (allucinazioni), P4 (eccitazione), P6
    (sospettosità/persecuzione), P7 (ostilità) e G9 (contenuto di pensiero insolito).
    9. Punteggio totale sulla scala di valutazione globale del funzionamento (GAF) = 50.
    10. Necessita di trattamento antipsicotico e trattamento monoterapico in corso a dose
    stabile (almeno da 4 settimane prima dello screening) a una dose terapeutica minima
    raccomandata o superiore di un antipsicotico (atipico o tipico, diverso dalla
    clozapina). L'uso corrente di quetiapina alla dose di 150 mg o inferiore durante la
    notte come sedativo non sarà considerato polifarmacia.
    11. Livello sintomatico attuale presente da almeno un mese, ma da meno di un anno.
    12. Il paziente è cooperativo, in grado di assumere farmaci per via orale, capace di
    comprendere le istruzioni e disposto e in grado di rispettare tutti gli aspetti dello
    studio.
    13. Il paziente vive con un prestatore di cure presso il suo domicilio, risiede in una
    struttura di assistenza o vive da solo ma ha a disposizione un prestatore di cure che
    aiuti a garantire l’aderenza al trattamento e il rispetto degli appuntamenti per le
    visite programmate in tutte le situazioni.
    14. Il paziente ha fornito consenso informato scritto prima di partecipare allo studio.
    15. Il paziente accetta di essere ricoverato in ospedale durante la notte se richiesto
    per le finalità dello studio o se lo sperimentatore lo ritiene necessario per garantire
    la sicurezza del paziente.
    E.4Principal exclusion criteria
    1. DSM-5 diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis
    2. History (within three months of study entry) or current diagnosis of Substance Use Disorder as defined by the DSM-5 criteria, with a severity of ‘moderate’ or ‘severe’, or patient is currently abusing drugs or alcohol or has done so in the past year
    3. Severity of current episode of psychosis requires that the patient be hospitalized
    4. Has a PANSS total score > 90 or a CGI-S rating of 7
    5. History or current diagnosis of other psychiatric or behavioral disorders
    6. Known suicidal risk, or a suicide attempt within the past 2 years
    7. History of neuroleptic malignant syndrome, priapism or moderate or severe tardive dyskinesia
    8. An advanced, severe, or unstable disease of any type that may interfere with any of the study evaluations
    9. Insulin-dependent diabetes mellitus
    10. History or current diagnosis of any neurodegenerative illness, dementia, significant concomitant neurological disease, organic cerebral disease, cerebrovascular disease, focal neurological lesions or history of any trauma resulting in loss of consciousness (during the past 2 years)
    11. History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures
    12. Prior surgery or current medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug
    13. Any clinically significant ECG abnormality, including a disorder of rate, rhythm, or conduction, or other morphological changes, or a QTcF interval prolongation
    14. Vital signs outside the following ranges:
    a. Systolic blood pressure < 90 or > 150 mmHg;
    b. Diastolic blood pressure < 50 or > 95 mmHg;
    c. Radial pulse (from vital signs) < 50 or > 100 bpm;
    d. Orthostatic hypotension
    15. History of hepatitis B and/or C, and/or positive serology results, which indicate the presence of hepatitis B and/or C
    16. Positive results from the HIV serology
    17. Positive results of the drug and alcohol tests at screening and/or baseline
    18. History of or current treatment with clozapine for psychosis
    19. Requires treatment with an anticholinergic drug, and the dose is not stable
    20. Receiving benzodiazepine therapy, unless the dose has been stabilized for at least 2 months
    21. Treatment with agents influencing dopamine, norepinephrine or serotonin neurotransmission
    22. Treatment with drugs capable of inducing/inhibiting hepatic enzyme metabolism (e.g. barbiturates, carbamazepine, phenylbutazone, phenytoin, primidone, rifampicin) four weeks prior to baseline or during the study
    23. Current treatment with sodium channel blockers or mood stabilizers; Valproic acid will be permitted, if used as maintenance treatment
    24. Exposure to any investigational drug within 5 weeks or 5 half-lives prior to screening
    25. A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to evenamide, or any components of the evenamide capsules
    26. Electroconvulsive therapy (ECT) or treatment with a transcranial magnetic stimulation (TMS) device within 6 months prior to screening
    27. Patient is female and of childbearing potential, pregnant or breastfeeding. For inclusion, female patients must be post-menopausal, surgically sterilized, or using adequate contraception
    28. Patients with a reasonable likelihood of non-compliance with the protocol, or any other reason that, in the Investigator’s opinion, would prohibit the inclusion of the patient in the study
    1. Diagnosi ai sensi del DSM-5 di disturbo schizofreniforme, disturbo schizoaffettivo o altra diagnosi psichiatrica primaria
    2. Anamnesi (nei tre mesi precedenti all'ingresso nello studio) o diagnosi attuale di disturbo da uso di sostanze, come definito dai criteri del DSM-5, di gravità pari a "moderato" o "grave", o abuso di droghe o alcol corrente o nell'anno precedente
    3. Episodio di psicosi attuale di gravità tale da richiedere il ricovero ospedaliero del paziente
    4. Punteggio totale sulla PANSS> 90 o un punteggio CGI-S di 7
    5. Anamnesi o diagnosi attuale di altri disturbi psichiatrici o comportamentali
    6. Rischio suicidario noto o tentativo di suicidio negli ultimi 2 anni
    7. Anamnesi di sindrome neurolettica maligna, priapismo o discinesia tardiva moderata o grave
    8. Malattia avanzata, grave o instabile di qualsiasi tipo che potrebbe interferire con una qualsiasi delle valutazioni dello studio
    9. Diabete mellito insulino-dipendente
    10. Anamnesi o diagnosi attuale di qualsiasi malattia neurodegenerativa, demenza, malattia neurologica concomitante significativa, malattia cerebrale organica, malattia cerebrovascolare, lesione neurologica focale o anamnesi di qualsiasi trauma con conseguente perdita di conoscenza (negli ultimi 2 anni)
    11. Anamnesi o diagnosi attuale di epilessia o disturbo convulsivo, o insorgenza di crisi convulsione nell'ultimo anno, o comparsa di crisi convulsive indotte da farmaci
    12. Precedente intervento chirurgico o condizione medica corrente che potrebbe interferire con l'assorbimento, la distribuzione, il metabolismo o l'escrezione del farmaco in studio
    13. Qualsiasi anomalia dell'ECG clinicamente significativa, incluso un disturbo della frequenza, del ritmo o della conduzione, oppure altri cambiamenti morfologici o un prolungamento dell'intervallo QTcF
    14. Segni vitali al di fuori dei seguenti intervalli:
    a. Pressione arteriosa sistolica < 90 o > 150 mmHg;
    b. Pressione arteriosa diastolica < 50 o > 95 mmHg;
    c. Polso radiale < 50 o > 100 pulsazioni/minuto;
    d. Ipotensione ortostatica

    15. Anamnesi di epatite B e/o C e/o risultati sierologici positivi, indicanti la presenza di epatite B e/o C
    16. Risultati positivi ai test sierologici dell’HIV
    17. Risultati positivi ai test antidroga e alcolemici allo screening e/o al basale
    18. Anamnesi o trattamento in corso con clozapina per la psicosi
    19. Necessità di trattamento con un farmaco anticolinergico e dose non stabile
    20. Terapia in corso con benzodiazepine, a meno che la dose non sia stabile da almeno 2 mesi
    21. Trattamento con agenti che influenzano la neurotrasmissione di dopamina, noradrenalina o serotonina
    22. Trattamento con farmaci in grado di indurre/inibire il metabolismo degli enzimi epatici (ad es. barbiturici, carbamazepina, fenilbutazone, fenitoina, primidone, rifampicina) quattro settimane prima del basale o durante lo studio
    23. Trattamento in corso con agenti bloccanti dei canali del sodio o stabilizzatori dell'umore; l'acido valproico sarà consentito se utilizzato come terapia di mantenimento
    24. Esposizione a qualsiasi farmaco sperimentale entro 5 settimane o 5 emivite prima dello screening
    25. Sensibilità farmacologica esagerata o ipersensibilità note a farmaci simili a evenamide o a qualsiasi componente delle capsule di evenamide
    26. Terapia elettroconvulsiva (TEC) o trattamento con un dispositivo di stimolazione magnetica transcranica (TMS) nei 6 mesi precedenti lo screening
    27. Paziente donna potenzialmente fertile, in gravidanza o in allattamento. Ai fini dell’inclusione, le pazienti di sesso femminile devono essere in post-menopausa, o sterilizzate chirurgicamente o utilizzare un metodo contraccettivo adeguato
    28. Pazienti con una ragionevole probabilità di non conformità al protocollo, o qualsiasi altra ragione che, secondo l'opinione dello sperimentatore, proibirebbe l'inclusione del paziente nello studio
    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
    The primary endpoint for assessment of efficacy will be at the 6-week (Day 43) time-point, as this is a standard period for assessing efficacy of antipsychotic drugs.
    L'endpoint primario verrà valutato a 6 settimane (day 43) in quanto è la finestra temporale standard per valutare l'efficacia di farmaci antipsicotici.
    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
    randomizzato in aperto con valutatore in cieco
    randomized open label with blinded 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)
    Patients could take parte into the 46-weeks extension study: patients who will not partecipate as those who will interrupt prematurely the treatment, will be asked to return to the site for a follow-up visit after 7 days from last drug intake. If the patient won't show to the 7 days follow up visit, the site staff will try to contact him/her for evaluating his/hers conditions. Furthermore, patients will be contacted by the site staff 30 days after last drug intake to assess possible SAE.
    I pazienti potranno partecipare all'estensione dello studio di 46 settimane: coloro che non parteciperanno così come colore che interrompono prematuramente la loro partecipazione,dovranno sottoporsi a una visita di follow-up 7 giorni dall'ultima dose di farmaco assunta. Se il paziente non si sottopone alla visita di follow-up dopo 7 giorni, verrà ricontattato per valutarne le condizioni. Inoltre, il paziente sarà contattato 30 giorni dopo l'ultima dose di farmaco per stabilire la presenza di SAE
    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 Opinion2021-02-24
    P. End of Trial
    P.End of Trial StatusOngoing
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