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    Summary
    EudraCT Number:2015-005814-31
    Sponsor's Protocol Code Number:ND0612H-012
    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:2021-01-14
    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 number2015-005814-31
    A.3Full title of the trial
    A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND)
    Studio multicentrico, internazionale, in aperto, volto a valutare la sicurezza di ND0612, una soluzione di
    levodopa/carbidopa somministrata tramite un sistema di infusione sottocutanea continua a pompa, in soggetti affetti da morbo di Parkinson in fase avanzata (BeyoND)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not available
    Non disponibile
    A.3.2Name or abbreviated title of the trial where available
    BeyoND
    BeyoND
    A.4.1Sponsor's protocol code numberND0612H-012
    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 SponsorNEURODERM LTD.
    B.1.3.4CountryIsrael
    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 supportNEuroDerm Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeuroDerm Ltd.
    B.5.2Functional name of contact pointLilach Zaddik
    B.5.3 Address:
    B.5.3.1Street AddressRuhrberg Science building - Bell entrance - 4th floor - 3 Pekeris St.
    B.5.3.2Town/ cityRehovot
    B.5.3.3Post code7670212
    B.5.3.4CountryIsrael
    B.5.4Telephone number0097289462729
    B.5.5Fax number0097289461729
    B.5.6E-maillilach@neuroderm.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 nameSoluzione di levodopa/carbidopa
    D.3.2Product code ND0612
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameLEVODOPA (LD)
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBIDOPA
    D.3.9.1CAS number 38821-49-7
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameCARBIDOPA (CD)
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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 Yes
    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
    advanced Parkinson's disease
    morbo di Parkinson in fase avanzata
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    morbo di Parkinson
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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
    The primary objective of the study is to assess the long term safety
    (systemic and local) and tolerability of continuous SC infusion of
    ND0612. Assessment will be based on adverse events of special interest (AESI), i.e.,
    infusion site reactions,cases of hypersensitivity, polyneuropathy.
    edema, pain, hematoma and nodules (local safety). Tolerability will be
    assessed based on the percentage of subjects that complete the 12
    month treatment period of the study and the percentage of subjects who
    discontinue from the 12-month treatment period due to an AE.
    Valutare la sicurezza a lungo termine (sistemica e locale) nonché valutare la
    tollerabilità dell'infusione SC continua di ND0612. La valutazione si baserà sugli
    eventi avversi (AE), con una particolare attenzione alle reazioni cutanee di
    particolare interesse (AESI), ossia reazioni al sito di infusione, casi di
    ipersensibilità e polineuropatia.
    La tollerabilità sarà valutata sulla base della percentuale dei soggetti che
    completano il periodo di trattamento di 12 mesi dello studio e la percentuale di
    soggetti che interrompe il trattamento a partire dal dodicesimo mese a causa di un
    evento avverso
    E.2.2Secondary objectives of the trial
    Further Safety Objectives: (assessed based on 12 month data):
    • To further assess the safety and tolerability of ND0612 including
    suicidality (Columbia - Suicide Severity Rating Scale [C-SSRS]),
    Questionnaire for Impulsive-Compulsive Disorders in PD-Rating Scale
    (QUIP RS), excessive daytime sleepiness (Epworth Sleepiness Scale
    [ESS]), vital signs, laboratory tests, and electrocardiogram (ECG) data.
    Further Safety Objective assessed based on data up to 36 months:
    • To assess the long-term safety (systemic and local) and tolerability of
    continuous SC infusion of ND0612. Assessment will be based on AEs,
    with a focus on infusion site skin reactions and infusion site inspections
    for erythema, edema, pain, hematoma and nodules (local safety).
    Ulteriori Obiettivi di Sicurezza (sulla base dei dati a 12 mesi): valutare ulteriormente la sicurezza e la tollerabilità di ND0612, tra cui la suicidalità (Scala di valutazione della gravità del suicidio - Columbia [C-SSRS]), i disordini impulsivo-compulsivi (scala di valutazione per il morbo di Parkinson (QUIP RS); l'eccessiva sonnolenza diurna (scala della sonnolenza Epworth [ESS]) parametri vitali, i risultati delle analisi di laboratorio e i dati dell’elettrocardiogramma (ECG).

    Ulteriori obiettivi di sicurezza valutati sulla base dei dati a 36 mesi (per i soggetti che continuano con il periodo di estensione del trattamento opzionale):
    • Valutare la sicurezza a lungo termine (sistemica e locale) e la tollerabilità dell’infusione SC continua di ND0612.
    [...] Descrizione completa nel protocollo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Pharmacokinetic (PK) sub-study for a clinical study protocol titled: A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND).
    Core Protocol Version: 6.2
    Date of PK sub-study Protocol: 04-Mar-2019

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sotto-studio di Farmacocinetica (PK) per un protocollo di studio clinico intitolato: Studio multicentrico, internazionale, in aperto volto a valutare la sicurezza di ND0612, una soluzione di levodopa/carbidopa somministrata tramite un sistema di infusione sottocutanea continua a pompa, in soggetti affetti da morbo di Parkinson in fase avanzata (BeyoND).
    Versione del Protocollo principale: 6.2
    Data del protocollo per il sotto-studio PK: 04-Mar-2019
    E.3Principal inclusion criteria
    To be eligible for study entry subjects in Cohort 1 (previously completed
    the treatment period in protocol ND0612H-006 within one month prior to
    enrolling to ND0612H-012) must satisfy all of the following criteria:
    1.Subject is able to, and has signed an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form
    (ICF).
    2.Subject has completed the treatment period of study
    ND0612H-006 not more than one month prior to enrolling in ND0612H-
    012.
    3.Willing and able to administer the SC infusion alone or with
    the assistance of a study partner and able to comply with the study
    specific procedures.
    To be eligible for study entry subjects in Cohort 2 (ND0612 naïve
    subjects and subjects who completed treatment in a ND0612 clinical
    study more than one month before screening) must satisfy all of the
    following criteria:
    1.Male and female PD subjects of any race aged at least 30
    years who sign an IRB/EC-approved ICF.
    2.PD diagnosis consistent with the UK Brain Bank Criteria.
    3.Modified Hoehn & Yahr scale in "ON" state of stage =3.
    4.Taking at least 4 doses/day of LD/DDI (or at least 3
    doses/day of Rytary) and taking, or have attempted to take, at least one
    other PD treatment for at least 30 days.
    5.Subjects must be stable on their anti-PD medications for at
    least 30 days before Day 1.
    6.Subjects may have had prior exposure to SC apomorphine
    injections/infusion but must have stopped continuous apomorphine
    administration at least 4 weeks before the screening visit. Treatment
    with apomorphine is prohibited during the entire ND0612 treatment
    period.
    7.Must have a minimum of 2 hrs of "OFF" time per day with
    predictable early morning "OFF" periods as estimated by the subject.
    8.Must have predictable and well defined early morning "OFF"
    periods with a good response to LD for treatment of the early morning
    "OFF" in the judgement of the investigator.
    9.Mini Mental State Examination (MMSE) score = 26.
    10.No clinically significant medical, psychiatric or laboratory
    abnormalities which the investigator judges would be unsafe or noncompliant
    in the study.
    11.Female subjects must be surgically sterile (hysterectomy,
    bilateral oophorectomy, or tubal ligation), postmenopausal (defined as
    cessation of menses for at least 1 year), or willing to practice a highly
    effective method of contraception. All female participants must be nonlactating
    and non-pregnant and have a negative urine pregnancy test at
    Screening and at Baseline. Female subjects of childbearing potential
    must practice a highly effective method of contraception (e.g., oral
    contraceptives, intrauterine devices, partner with vasectomy), 1 month
    before enrollment, for the duration of the study, and 3 months after the
    last dose of study drug. Alternatively, true abstinence is acceptable
    when it is in line with the subject's preferred and usual lifestyle. If a
    subject is usually not sexually active but becomes active, the subject and
    sexual partner must comply with the contraceptive requirements
    detailed above.
    12.Willing and able to administer the SC infusion alone or with
    the assistance of a study partner after a screening period of up to 40
    days and willing and able to comply with study requirements.
    13. Subjects should have a named study partner
    Per poter essere idonei ed entrare a far parte dello studio, i soggetti della coorte 1 (ovvero i soggetti che hanno completato il periodo di trattamento nel protocollo ND0612H-006 nel mese precedente l’arruolamento nello studio ND0612H-012) devono soddisfare tutti i seguenti criteri:
    1. Essere in grado di firmare e aver firmato un modulo di consenso informato (ICF) approvato da un Comitato di revisione istituzionale/Comitato etico (IRB-EC).
    2. Aver completato il periodo di trattamento dello studio ND0612H-006 da non più di aperto un mese prima dell’arruolamento nello studio ND0612H-012.
    3. Devono essere disposti e devono essere in grado di somministrarsi da soli l'infusione SC oppure mediante l'aiuto da parte di un partner dello studio e devono anche essere in grado di rispettare tutte le procedure specifiche dello studio.

    Per poter essere idonei ed entrare a far parte dello studio, i soggetti della coorte 2 (soggetti naïve aND0612 e soggetti che hanno completato il trattamento nello studio clinico ND0612H-006 da più di un mese prima dello screening) devono soddisfare i seguenti criteri:
    1. Soggetti con morbo di Parkinson, di sesso maschile o femminile, di qualsiasi etnia ed età pari ad almento 30 anni, che abbiano firmato il modulo di consenso informato (ICF) approvato dall'IRB/EC.
    2. Diagnosi di morbo di Parkinson conforme ai criteri della UK Brain Bank.
    3. Punteggio per la stadiazione secondo la Scala di Hoehn & Yahr modificata per la fase "ON" =3.
    4. Assunzione di almeno 4 dosi/giorno di LD/DDI (o almeno 3 dosi/giorno di Rytary) e assunzione, o tentativo di assunzione, di almeno 1 altro trattamento per il morbo di Parkinson per almeno 30 giorni.
    5. I soggetti devono essere in terapia stabile per il morbo di Parkinson da almeno 30 giorni prima del giorno 1.
    6. I soggetti possono essere stati precedentemente sottoposti a iniezioni/infusioni SC di apomorfina, ma la somministrazione continua di apomorfina deve essere stata interrotta da almeno 4 settimane prima della visita di screening. Durante l'intero periodo di trattamento con ND0612 è vietato il trattamento con apomorfina.
    7. Devono manifestare un minimo di 2 ore di fase "OFF" al giorno con fasi "OFF" mattutine prevedibili, come stimato dal soggetto.
    8. A giudizio dello sperimentatore, devono manifestare fasi "OFF" mattutine prevedibili e ben definite, con una buona risposta a LD per il trattamento delle fasi "OFF" mattutine.
    9. Punteggio per il Mini-Mental State Examination (MMSE) =26.
    10. Non devono presentare anomalie di laboratorio, psichiatriche o mediche significative da un punto di vista clinico che, a giudizio dello sperimentatore, potrebbero compromettere la sicurezza o risultare non conformi allo studio.
    11. I soggetti dello studio di sesso femminile devono essere chirurgicamente sterili (essere state sottoposte a isterectomia, ovariectomia bilaterale o a legatura delle tube), in postmenopausa (definita come la cessazione delle mestruazioni da almeno 1 anno) o disposte a utilizzare un metodo contraccettivo altamente efficace. Le donne partecipanti allo studio non devono allattare al seno né essere in stato di gravidanza e il risultato del test di gravidanza su urina allo screening e alla visita basale deve essere negativo. I soggetti dello studio di sesso femminile potenzialmente fertili devono utilizzare un metodo di contraccezione efficace (ad es. contraccettivi orali, dispositivi intrauterini, partner con vasectomia), da 1 mese prima dell'arruolamento, per tutta la durata dello studio e per 3 mesi dopo l'ultima dose del farmaco dello studio. In alternativa, è accettabile la reale astinenza dai rapporti sessuali, quando ciò è in linea con lo stile di vita preferito e usuale del soggetto. Se un soggetto non attivo sessualmente, lo diventa, il soggetto e il/la suo/a partner dovranno attenersi ai requisiti di contraccezione descritti in dettaglio sopra.
    [...] Per l'elenco completo si veda il protocollo.
    E.4Principal exclusion criteria
    Subjects in Cohort 1 and Cohort 2 will be excluded from the study if one
    or more of the following criteria listed below are applicable.
    1.Previously unable to tolerate ND0612 and/or have experienced intolerable adverse drug reactions associated with its use,
    regardless of the dosing regimen administered.
    For Cohort 2 the following exclusion criteria apply:
    1.Atypical or secondary parkinsonism.
    2.Acute psychosis or hallucinations in past 6 months.
    3.Any relevant medical, surgical, or psychiatric condition,
    laboratory value, or concomitant medication which, in the opinion of the
    Investigator makes the subject unsuitable for study entry or potentially
    unable to complete all aspects of the study.
    4.Any malignancy in the 5 years prior to randomization
    (excluding basal cell carcinoma of the skin or cervical carcinoma in situ
    that have been successfully treated).
    5.Positive serum serology for Hepatitis B Virus (HBV),
    Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the
    Screening visit
    6.Prior neurosurgical procedure for PD, or Duodopa treatment
    7.Subjects with a history of drug abuse or alcoholism within
    the past 12 months.
    8.Clinically significant ECG rhythm abnormalities.
    9.Renal or liver dysfunction that may alter drug metabolism
    including: serum creatinine >1.3 mg/dL, serum aspartate
    aminotransferase (AST) or alanine aminotransferase (ALT) >2 x upper
    limit of normal (ULN), total serum bilirubin >2.5 mg/dL.
    10. Current participation in a clinical trial with an
    investigational product or past participation within the last 30 days
    before Day 1.
    Per la coorte 1 e la coorte 2 si applicano i seguenti criteri di esclusione:
    1. Non in grado di tollerare ND0612 in precedenza e/o che abbiano manifestato reazioni avverse al farmaco intollerabili associate all'uso dello stesso farmaco, indipendentemente dal regime di dosaggio somministrato.

    Per la coorte 2 si utilizzano i seguenti criteri di esclusione:
    1. Parkinsonismo atipico o secondario.
    2. Allucinazioni o psicosi acute negli ultimi 6 mesi.
    3. Qualsiasi condizione medica, chirurgica o psichiatrica o qualsiasi valore di laboratorio o qualsiasi farmaco concomitante di una certa rilevanza che, secondo lo sperimentatore, rendano il soggetto non idoneo ad entrare nello studio oppure potenzialmente incapace di completare tutti gli aspetti dello studio.
    4. Qualsiasi malignità nei 5 anni che precedono la randomizzazione(escluso il carcinoma a cellule basali della pelle o il carcinoma della cervice in situ trattato con successo).
    5. Test su siero positivo per infezione da virus dell’epatite B (HBV), da virus dell’epatite C (HCV) o da virus dell’immunodeficienza umana (HIV) alla visita di screening.
    6. Essere stato sottoposto in passato a una procedura neurochirugica per il morbo di Parkinson o trattamento con duodopa.
    7. Soggetti con anamnesi clinica di abuso di droghe o alcolismo negli ultimi 12 mesi.
    8. Anomalie del ritmo cardiaco evidenziate da tracciato ECG che risultino significative da un punto di vista clinico.
    9. Disfunzione renale o epatica che può alterare il metabolismo dei farmaci come: creatinina sierica >1,3 mg/dl, aspartato aminotransferasi sierica (AST) o alanina aminotransferasi (ALT) >2 x il limite superiore di normalità (ULN), bilirubina sierica totale >2,5 mg/dl.
    10. Partecipazione in corso, o negli ultimi 30 giorni prima del giorno 1, a una sperimentazione clinica su un medicinale sperimentale.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is a safety endpoint assessing AEs,
    with a focus on infusion site skin reactions of continuous SC infusion of
    ND0612 throughout the study period. Local safety at the infusion sites
    will be assessed as the proportion of subjects with clinically significant
    skin reactions and severity of skin reactions according to the following
    local safety parameters: erythema, edema, pain, hematoma and nodules.
    L'endpoint primario per questo studio è l'endpoint di sicurezza atto a valutare gli AE, con una particolare attenzione alle reazioni cutanee al sito di infusione per l'infusione SC continua di ND0612 per tutta la durata dello studio. La sicurezza locale a livello dei siti di iniezione sarà valutata come la percentuale di soggetti che manifestano reazioni cutanee clinicamente significative e la gravità delle reazioni cutanee in base ai seguenti parametri di sicurezza locale: eritema, edema, dolore, ematomi e noduli.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12 visit
    visita mese 12
    E.5.2Secondary end point(s)
    The secondary safety endpoints to be assessed for the 12-month treatment period include:
    • Assessment of suicidal behavior and ideation (C-SSRS responses, including the number of subjects experiencing at least 1 event of suicidal ideation, at least 1 event of suicidal behavior, at least 1 event of suicidal ideation or behavior and selfinjurious behavior without suicidal intent, changes from Baseline in C-SSRS categories (No Suicidal Ideation or Behavior, Suicidal Ideation and Suicidal Behavior) and changes from Baseline in C-SSRS suicidal ideation)
    • Assessment of impulsive compulsive behavior (QUIP-RS total scores)
    • Epworth Sleepiness Scale (ESS total score)
    • Vital signs with a focus on orthostatic BP (possible dopaminergic side effect)
    • Laboratory data (hematology and biochemistry), including dipstick urinalysis results evaluation
    • 12-lead ECG parameters, including ECG interpretation of clinical significance
    • Physical examination
    • Prior and concomitant medications

    The exploratory efficacy endpoints assessed for 12 months of treatment are:
    • Change in daily "ON" time without troublesome dyskinesia (defined as the sum of "ON" time without dyskinesia and "ON" time with non-troublesome dyskinesia) from Baseline to the 12-month visit based on home "ON/OFF" diaries.
    * Change in daily "OFF" time from Baseline to the 12 month visit, based on "ON/OFF" home diaries
    * Change in total daily dose of oral LD/DDI from Baseline to the 12 month visit
    • Proportion of responders at the 12-month visit based on daily "OFF" time recorded in home "ON/OFF" diaries. A responder is defined as a subject that experiences =50% reduction in "OFF" time from Baseline.
    • Change in daily "ON" time with troublesome dyskinesia in a subset of subjects who had more than 1 hour of troublesome dyskinesia at Baseline, based on home "ON/OFF" diaries from Baseline to the 12-month visit.
    * Change in PDQ-39 scores from Baseline to the 12 month visit
    * Change in EQ-5D-5L scores from Baseline to the 12 month visit
    * Change in UPDRS Part II (ADL) from Baseline to the 12 month visit
    * Change in CGI-Severity and CGI-Improvement from Baseline to the 12 month visit
    * Change in SGI-Improvement from Baseline to the 12 month visit
    * Change in PDSS total score from Baseline to the 12 month visit
    * Change in UPDRS Part III (motor score) from Baseline to the 12 month visit
    * Change from baseline to month 12 in percentage of “OFF” time and percentage of ‘Good’ ON during the first 3 hours since the subject is awake after 06:00 (6 am).
    * Change from baseline to month 12 in ND0612 total dose.
    * Proportion of patients who reduced ND0612 total dose at any time during the study.
    Si veda riquadro in inglese, qui sotto.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 12 visita
    visita mese 12
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    verranno studiati 2 dosaggi dello stesso IMP: Regime 1 (720 LD/90 CD) vs Regime 2 (537,6 LD/67,2 CD)
    2 dosages of IMP will be studied: Regimen 1 (720 LD/90 CD) vs Regimen 2 (537,6 LD/67,2 CD)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Austria
    Czechia
    France
    Israel
    Italy
    Poland
    United States
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months4
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 210
    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)
    If the product is not commercially available at the end of the 12-month treatment period, subjects will be allowed to continue with study treatment for an optional treatment extension period of 24 more months.
    At the end of the optional treatment period, subjects will be allowed to continue with study treatment for another optional long term treatment extension period of up to 24 more months in which clinic visits will continue to be performed every 3 months to assess subject long-term safety.
    Se il prodotto non è disponibile in commercio al termine dei 12 mesi di trattamento, ai soggetti sarà consentito di continurare il trattamento in studio per un periodo opzionale di estensione del trattamento di ulteriori 24 mesi. A seguire, ai soggetti sarà offerto un altro periodo opzionale di estensione del trattamento a lungo termine fino a ulteriori 24 mesi durante i quali le visite in ospedale continueranno ogni 3 mesi per valutare la sicurezza a lungo termine.
    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 Decision2016-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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