Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42568   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-004156-37
    Sponsor's Protocol Code Number:ND0612-317
    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:2021-06-17
    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 number2018-004156-37
    A.3Full title of the trial
    A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease experiencing motor fluctuations (BouNDless)
    Sperimentazione clinica multicentrica, randomizzata, controllata contro controllo attivo, in doppio cieco, a doppia simulazione, a gruppi paralleli per valutare l’efficacia, la sicurezza e la tollerabilità dell’infusione continua sottocutanea di ND0612 rispetto a LD/CD a rilascio immediato (IR) per via orale in soggetti con malattia di Parkinson che presentano fluttuazioni motorie (BouNDless)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson's disease (BouNDless)
    Studio Clinico per valutare l’efficacia, la sicurezza e la tollerabilità dell’infusione continua sottocutanea di ND0612 rispetto a trattamento per via orale in soggetti con malattia di Parkinson che presentano (BouNDless)
    A.3.2Name or abbreviated title of the trial where available
    BouNDless
    BouNDless
    A.4.1Sponsor's protocol code numberND0612-317
    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 pointGalit Shaltiel-Gold,
    B.5.3 Address:
    B.5.3.1Street AddressRuhrberg Science building, 3 Pekeris St.
    B.5.3.2Town/ cityRehovot
    B.5.3.3Post code7670212
    B.5.3.4CountryIsrael
    B.5.4Telephone number0097289462729234
    B.5.5Fax number0097289461729
    B.5.6E-mailgalits@neuroderm.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 IR LD / CD
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Pharma, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCarbidopa and Levodopa tablets, USP
    D.3.2Product code [NA]
    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.3.8INN - Proposed INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 codeNA
    D.3.9.4EV Substance CodeSUB06126MIG
    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) 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 namelevodopa/carbidopa solution
    D.3.2Product code [ND0612]
    D.3.4Pharmaceutical form Concentrate for 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 codeLEVODOPA
    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 codeCARBIDOPA
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's disease
    Malattia di Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    Malattia 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.1.3Condition 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 determine the effect of ND0612 on daily "ON" time without troublesome dyskinesia (defined as the sum of "ON" time without dyskinesia and "ON" time with non-troublesome dyskinesia) using subject-completed "ON/OFF" diary assessments of motor function in subjects with Parkinson's disease (PD) experiencing motor fluctuations.
    L’obiettivo primario dello studio è determinare l’effetto di ND0612 sul periodo “ON” giornaliero senza discinesia problematica (definito come la somma di periodo “ON” senza discinesia e periodo “ON” con discinesia non problematica) in soggetti con malattia di Parkinson (PD) che presentano fluttuazioni motorie utilizzando le valutazioni della funzione motoria nel diario. “ON/OFF” compilato dai soggetti.
    E.2.2Secondary objectives of the trial
    Key secondary objective of the study is to determine the effect of ND0612 on daily "OFF" time in subjects with PD experiencing motor fluctuations using subject-completed "ON/OFF" diary assessments of motor function.
    L’obiettivo secondario principale dello studio è determinare l’effetto di ND0612 sul periodo “OFF” giornaliero in soggetti con PD che presentano fluttuazioni motorie utilizzando le valutazioni della funzione motoria nel diario “ON/OFF” compilato dai soggetti.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: 1.0
    Date: 12/04/2019
    Title: There is an optional pharmacogenetics sub study
    Objectives: To analyze the correlation of potential genetic variations and clinical treatment responses to study drug

    Farmacogenetica
    Versione: 1.0
    Data: 12/04/2019
    Titolo: sottostudio di farmacogenetica facoltativo
    Obiettivi: Analizzare la correlazione tra le potenziali variazioni genetiche e le risposte del trattamento clinico al farmaco dello studio
    E.3Principal inclusion criteria
    1. Male and female subjects with PD of any race at least 30 years of age who sign an Institutional Review Board/Ethics Committee–approved informed consent form (ICF).
    2. Parkinson's disease diagnosis consistent with the UK Brain Bank Criteria.
    3. Modified Hoehn and Yahr scale in "ON" stage = 3.
    4. Subjects must experience motor fluctuations and experience an average of at least 2.5 hours daily (with a minimum of 2 hours every day) in the "OFF" state during the waking hours as confirmed by an adequately completed "ON/OFF" diary over 3 days.
    5. Subject treatment should be at least 4 doses/day of LD/ Dopa Decarboxylase Inhibition (DDI) (or at least 3 doses/day of extended release LD/DDI, e.g., Rytary) and at least 400 mg/day of LD, or equivalent according to the conversion table, and, according to the Investigator's judgement, the subject experiences motor fluctuations that cannot be further improved by adjusting anti-PD medications.
    6. Subjects and/or study partners have no impediment that may prevent them from operating the pump system.
    7. Subjects and/or study partners must demonstrate ability to keep accurate diary entries of PD symptoms ("ON/OFF" diaries) with at least 75% concordance with the Blinded Efficacy Rater by the end of the diary training session during the Screening Period, including at least 1 "OFF" assessment.
    8. Mini Mental State Examination (MMSE) score = 24.
    9. 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 subjects must be non-lactating and
    not pregnant and have a negative urine pregnancy test at Screening and
    at Enrollment (IR D1/ V2). Female subjects of childbearing potential
    must practice a highly effective method of contraception (such methods
    include combined [estrogen and progestogen containing] hormonal
    contraception associated with inhibition of ovulation: oral / intravaginal;
    transdermal / progestogen-only hormonal contraception associated with
    inhibition of ovulation: oral / injectable; implantable / intrauterine
    device [IUD] / intrauterine hormone-releasing system [IUS]/ bilateral
    tubal occlusion / vasectomized partner/ sexual abstinence) from 1
    month before Enrollment (IR D1/V2) until 1 month after the last dose of
    study treatment. 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.
    10. Willingness and ability to comply with study requirements.
    11. Subjects must have a named study partner that signed the ICF.
    12. Approval for entry into the study by an independent EAC.
    1. Soggetti di sesso maschile e femminile con PD di qualsiasi razza, di almeno 30 anni d’età, che firmano un modulo di consenso informato (ICF) approvato dal comitato etico.
    2. Diagnosi di malattia di Parkinson coerente con i criteri della Brain Bank del Regno Unito.
    3. Scala modificata di Hoehn e Yahr in fase “ON” = 3.
    4. I soggetti devono manifestare fluttuazioni motorie con una media di almeno 2,5 ore al giorno (con un minimo di 2 ore ogni giorno) nello stato “OFF” durante le ore di veglia, come confermato da un diario “ON/OFF” adeguatamente compilato per 3 giorni.
    5. Il trattamento del soggetto deve consistere in almeno 4 dosi/giorno di LD/ Inibitore di dopa decarbossilasi (DDI) (o almeno 3 dosi/giorno di esteso rilascio LD/DDI, e.s., Rytary) e almeno 400 mg/giorno di LD, o equivalente secondo la tabella di conversione, e, secondo il parere dello sperimentatore, il soggetto manifesta fluttuazioni motorie, che non possono essere ulteriormente migliorate regolando i farmaci anti-PD.
    6. I soggetti e/o partner dello studio senza alcun impedimento a far funzionare il sistema a pompa.
    7. I soggetti e/o partner dello studio devono dimostrare la capacità di mantenere un accurato inserimento delle voci del diario sui sintomi della PD (diari “ON/OFF”) con almeno il 75% di concordanza con il valutatore di efficacia in cieco entro la fine della sessione formativa sul diario, durante il periodo di screening, inclusa almeno 1 valutazione “OFF”.
    8. Punteggio del Mini esame dello stato mentale (MMSE) = 24.
    9. I soggetti di sesso femminile devono essere chirurgicamente sterili (isterectomia, ovariectomia bilaterale o legatura delle tube); in post-menopausa (definita come cessazione del ciclo mestruale da almeno 1 anno); o disposte ad adottare un metodo di contraccezione altamente efficace. Tutti i soggetti di sesso femminile non devono essere in fase di allattamento e incinte e devono avere un test di gravidanza sulle urine negativo allo screening e all’arruolamento (IR1 G1). I soggetti di sesso femminile potenzialmente fertili devono adottare un metodo contraccettivo altamente efficace (per es., tali metodi
    includono ormonali combinati [contenenti estrogeni e progestinici]
    contraccezione associata all'inibizione dell'ovulazione: orale / intravaginale;
    contraccezione ormonale transdermica / solo progestinica associata a
    inibizione dell'ovulazione: orale / iniettabile; impiantabile / intrauterino
    dispositivo [IUD] / sistema di rilascio dell'ormone intrauterino [IUS] / bilaterale
    occlusione tubarica / partner vasectomizzato / astinenza sessuale), da 1 mese prima dell’arruolamento (IR1 G1) fino a 1 mese dopo l’ultima dose di trattamento dello studio. In alternativa, è accettabile l’astinenza totale se in linea con lo stile di vita preferito e abituale del soggetto. Se un soggetto di solito non è sessualmente attivo ma diventa attivo, il soggetto e il/la Suo/a partner sessuale deve attenersi ai requisiti contraccettivi di cui sopra.
    10. Disponibilità e capacità di attenersi ai requisiti dello studio.
    11. I soggetti devono avere un partner dello studio indicato che ha firmato l’ICF.
    12. Approvazione per l’ingresso nello studio da parte di un Comitato EAC.
    E.4Principal exclusion criteria
    1. Atypical or secondary Parkinsonism.
    2. Acute psychosis or troublesome hallucinations in the past 6 months.
    3. Subjects with clinically significant or unstable medical, surgical, or psychiatric condition or laboratory abnormalities which, in the opinion of the Investigator or the EAC, represents a safety risk, makes the subject unsuitable for study entry, or potentially unable to complete all aspects of the study.
    4. Clinically significant ECG abnormalities.
    5. Renal or liver dysfunction that may alter drug metabolism including Screening Visit serum levels of creatinine > 1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 × upper limit of normal, and total bilirubin > 2.5 mg/dL.
    6. Any malignancy in the 5 years before enrollment, excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated.
    7. Use of subcutaneous (SC) apomorphine injections, sublingual apomorphine, or inhaled LD within 4 weeks before the enrollment.
    8. Concomitant therapy or within 28 days before enrollment with: metoclopramide, reserpine, methylphenidate, or amphetamines, well as neuroleptics; exception in case of Quetiapine and Pimavanserin use: (1) allowed only in case it had been used for a period of at least 3 months before enrollment, (2) subject is on stable therapy for at least 3 months (3) underlying psychosis to be under control and anticipating no changes to the dosage of the medication throughout the study.
    9. Subjects with a history of alcohol or substance abuse within the past 12 months.
    10. Subjects who have taken experimental medications within 30 days before enrollment.
    11. Subjects who have previously participated in studies ND0612H-006 and/or ND0612H-012.
    12. Subjects who have previously undergone treatment for PD with a surgical intervention (e.g., pallidotomy, thalamotomy, transplantation, deep brain stimulation procedures), Duodopa®/Duopa®, or continuous dopaminergic or apomorphine infusion. Subjects who have discontinued Duodopa®/Duopa® treatment at least 6 months before enrollment and
    have undergone stoma closure surgery at least 6 months before enrollment, may be included in this study. Subjects who are planning to undergo treatment for PD with a surgical intervention will be enrolled at the Investigator's discretion.
    13. Subjects with severe disabling dyskinesias, based on Investigator's
    discretion.
    14. History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of different lesions (e.g., sunburn, acne, scar tissue, tattoo, open wound, branding, or pigmentation) that, in the Investigator's opinion, would interfere with the infusion of the study drug or could interfere with study assessments.
    15. Subjects who do not have sufficient SC tissue for SC infusion treatment.
    16. Use of non-selective monoamine oxidase inhibitors (e.g., phenelzine, isocarboxazid, tranylcypromine) within 4 weeks before enrollment.
    17. Use of monoamine-depleting agents (e.g., reserpine, tetrabenazine, deutetrabenazine, valbenazine, xenazine) within 4 weeks before enrollment.
    18. Current or previous diagnosis of Dopamine Dysregulation Syndrome or Impulse Control Disorder.
    19. Current Impulse Control Disorder in the last 5 years.
    20. Subjects who answered "yes" to questions 4 or 5 of the C-SSRS
    within the last 5 years.
    21. Known allergy to the study drug or placebo or any of their excipients.
    22. History of narrow angle glaucoma
    1. Parkinsonismo secondario o atipico.
    2. Psicosi acuta o allucinazioni problematiche negli ultimi 6 mesi.
    3. Soggetti con condizione medica, chirurgica o psichiatrica clinicamente significativa o instabile, oppure con anomalie di laboratorio che, a giudizio dello sperimentatore o dell’EAC, rappresenta un rischio di sicurezza, rende il soggetto inadatto all’ingresso nello studio o potenzialmente non in grado di completare tutti gli aspetti dello studio.
    4. Anomalie all’ECG clinicamente significative.
    5. Insufficienza renale o disfunzione epatica che possono alterare il metabolismo del farmaco tra cui, alla visita di screening, livelli sierici di creatinina > 1,5 mg/dl, aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) > 2 × limite superiore della norma e bilirubina totale > 2,5 mg/dl.
    6. Qualsiasi tumore maligno nei 5 anni precedenti l’arruolamento, escluso il carcinoma cutaneo basocellulare o il carcinoma cervicale in situ che sono stati trattati con successo.
    7. Uso di iniezioni sottocutanee (SC) di apomorfina, apomorfina sublinguale o LD inalata nelle 4 settimane precedenti l’arruolamento.
    8. Terapia concomitante o nei 28 giorni precedenti l’arruolamento con: metoclopramide, reserpina, metilfenidato, o anfetamine, nonché i neurolettici; eccetto nel caso di uso di quetiapina e pimavanserina: (1) consentito solo nel caso in cui sia stato utilizzato per un periodo di almeno 3 mesi prima dell’arruolamento, (2) il soggetto è sotto terapia stabile da almeno 3 mesi (3) psicosi sottostante da tenere sotto controllo e anticipando l’assenza di modifiche al dosaggio del farmaco per tutta la durata dello studio.
    9. Soggetti con un passato di abuso di stupefacenti o alcool nei 12 mesi precedenti.
    10. Soggetti che hanno assunto farmaci sperimentali nei 30 giorni precedenti all’arruolamento.
    11. Soggetti che in precedenza hanno partecipato a studi con ND0612H-006 e/o ND0612H-012.
    12. Soggetti che sono stati precedentemente sottoposti a trattamento per PD con un intervento chirurgico (per es., pallidotomia, talamotomia, trapianto, procedure di stimolazione cerebrale profonda); Duodopa®/Duopa®; oppure infusione continua di dopaminergici o apomorfina. Possono essere inclusi in questo studio i soggetti che hanno interrotto il trattamento con Duodopa/Duopa almeno 6 mesi prima dell’arruolamento e sono stati sottoposti a intervento chirurgico per chiusura della stomia almeno 6 mesi prima dell’arruolamento in questo studio. I soggetti che stanno programmando di sottoporsi al trattamento per PD con un intervento chirurgico saranno arruolati a discrezione dello Sperimentatore.
    13. Soggetti con gravi discinesie invalidanti, a discrezione dello sperimentatore
    14. Anamnesi di patologie o disturbi cutanei significativi (per es., la psoriasi, la dermatite atopica, ecc.) o evidenza di lesioni diverse (per es., scottature, acne, tessuto cicatriziale, tatuaggi, ferite aperte, marcature o pigmentazione) che, a parere dello Sperimentatore, interferirebbe con l’infusione del farmaco dello studio o che potrebbe interferire con le valutazioni dello studio.
    15. Soggetti che non dispongono di una quantità sufficiente di tessuto SC per il trattamento con infusione SC.
    16. Uso di inibitori delle monoamino ossidasi non selettivi, (ad esempio, fenelzina, isocarbossazide, tranilcipromina) nelle 4 settimane prima dell’arruolamento.
    17. Uso di agenti di deplezione-monoaminici (per es., reserpina, tetrabenazina, deutetrabenazina, valbenazina, xenazina) nelle 4 settimane prima dell’arruolamento.
    18. Diagnosi attuale o precedente di Sindrome da alterata regolazione della dopamina o Disturbi del controllo degli impulsi.
    19. Attuale disturbo del controllo degli impulsi negli ultimi 5 anni.
    20. Soggetti che hanno risposto "sì" alle domande 4 o 5 del C-SSRS
    negli ultimi 5 anni.
    21. Nota allergia al farmaco dello studio o al placebo o a qualsiasi loro eccipiente.
    22. Storia di glaucoma ad angolo stretto
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from Baseline to the end of the DBDD Maintenance Period (DB W12) in the mean duration of "ON" time without troublesome dyskinesia adjusted to subject's waking hours and normalized to 16 waking hours, based on subject's "ON/OFF" diary assessments on the 3 consecutive days before the visit. "ON" time without troublesome dyskinesia is defined as the sum of "ON" time without dyskinesia and "ON" time with non-troublesome dyskinesia.
    L’endpoint primario è la variazione rispetto al basale alla fine del periodo di mantenimento DBDD (DB S12) nella durata media del periodo “ON” senza discinesia problematica regolata in funzione delle ore di veglia del soggetto e normalizzata a 16 ore di veglia, in base alle valutazioni nel diario “ON/OFF” del soggetto nei 3 giorni consecutivi prima della visita. Il periodo “ON” senza discinesia problematica viene definito come il totale di periodo “ON” senza discinesia e periodo “ON” con discinesia non problematica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the DBDD Maintenance Period (DB W12)
    La fine del periodo di mantenimento DBDD (DB S12)
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoint is the change from Baseline to the end of the DBDD Maintenance Period (DB W12) in the mean duration (hours) of "OFF" time adjusted to subject's waking hours and normalized to 16 waking hours, based on subject's "ON/OFF" diary assessments on the 3 consecutive days before the visits.
    Il principale endpoint secondario di efficacia è la variazione rispetto al basale alla fine del periodo di mantenimento DBDD (DB S12) nella durata media (ore) di periodo “OFF” regolata in funzione delle ore di veglia del soggetto e normalizzata a 16 ore di veglia, in base alle valutazioni nel diario “ON/OFF” del soggetto nei 3 giorni consecutivi prima delle visite.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the DBDD Maintenance Period (DB W12)
    La fine del periodo di mantenimento DBDD (DB S12)
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    Belgium
    Czechia
    France
    Hungary
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Portugal
    Russian Federation
    Serbia
    Slovakia
    Spain
    Ukraine
    United Kingdom
    United States
    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 years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days13
    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: 207
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 275
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 198
    F.4.2.2In the whole clinical trial 482
    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)
    Optional open label part of the study is created to provide patients with study drug for another year (if they want). Standard care of treatment will be available after study ends.
    E' previsto, per i pazienti che accettano, un periodo opzionale di estensione del trattamento in aperto per un ulteriore anno. La terapia standard di trattamento sarà disponibile dopo la fine dello studio.
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-22
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA