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    Summary
    EudraCT Number:2020-002754-24
    Sponsor's Protocol Code Number:BIA-91067-403
    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:2021-08-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002754-24
    A.3Full title of the trial
    A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson's Disease.
    Studio esplorativo, randomizzato, a gruppi paralleli, multicentrico, multinazionale, prospettico, in aperto, volto a valutare l'effetto aggiuntivo di 50 mg di opicapone o 100 mg di levodopa come prima strategia per il trattamento del fenomeno wearing-off in pazienti affetti da malattia di Parkinson.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations.
    Studio clinico con pazienti affetti da malattia di Parkinson in fase iniziale, per indagare l'effetto di Opicapone 50 mg o Levodopa 100 mg nel trattamento delle fluttuazioni motorie.
    A.3.2Name or abbreviated title of the trial where available
    ADOPTION: eArly levoDopa with Opicapone in Parkinson's paTients wIth motOr fluctuatioNs
    ADOPTION: levodopa precoce con opicapone nei pazienti affetti da Parkinson con fluttuazioni motorie
    A.4.1Sponsor's protocol code numberBIA-91067-403
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03959540
    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 SponsorBIAL-Portela & Ca, S.A.
    B.1.3.4CountryPortugal
    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 supportBial - Portela & Ca, S.A.
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBial - Portela & Ca, S.A.
    B.5.2Functional name of contact pointRaquel Costa, PharmD
    B.5.3 Address:
    B.5.3.1Street AddressÀ Av. da Siderurgia Nacional
    B.5.3.2Town/ cityCoronado (S. Romão e S. Mamede)
    B.5.3.3Post code4745-457
    B.5.3.4CountryPortugal
    B.5.4Telephone number00351229866100
    B.5.5Fax number00351229866198
    B.5.6E-mailRaquel.Costa@bial.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 Yes
    D.2.1.1.1Trade name SINEMET 100 mg + 25 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMSD Italia S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameSINEMET 100 mg + 25 mg compresse
    D.3.2Product code [023145028]
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeNot available
    D.3.9.3Other descriptive nameLevodopa
    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.3.9.2Current sponsor codeNot available
    D.3.9.3Other descriptive nameCarbidopa
    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.2.1.1.1Trade name Madopar 125 mg T, tablets
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    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 nameMadopar® 125 mg T Tablets Levodopa 100 mg Benserazide 25 mg (as benserazide hydrochloride)
    D.3.2Product code [6036937.00.01]
    D.3.4Pharmaceutical form Tablet
    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 INNBENSERAZIDE HYDROCHLORIDE
    D.3.9.1CAS number 14919-77-8
    D.3.9.2Current sponsor codeNot available
    D.3.9.4EV Substance CodeSUB00706MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevodopa
    D.3.9.2Current sponsor codeNot available
    D.3.9.3Other descriptive nameLevodopa
    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.3.11 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 Yes
    D.2.1.1.1Trade name Ongentys 50 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderBial – Portela & Cª, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOngentys 50 mg capsule rigide
    D.3.2Product code [BIA 9-1067]
    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 INNOpicapone
    D.3.9.1CAS number 923287-50-7
    D.3.9.2Current sponsor codeNot Available
    D.3.9.3Other descriptive nameOpicapone
    D.3.9.4EV Substance CodeSUB130629
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Parkinson's Disease (PD)
    La malattia di Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease (PD)
    La 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 HLT
    E.1.2Classification code 10034005
    E.1.2Term Parkinson's disease and parkinsonism
    E.1.2System Organ Class 100000004852
    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 add-on efficacy of opicapone 50 mg or an extra dose of L-DOPA 100 mg as first strategy for the treatment of wearing-off in patients with PD.
    Valutare l'efficacia aggiuntiva di opicapone 50 mg o di una dose aggiuntiva di L-DOPA 100 mg come prima strategia per il trattamento del wearing-off nei pazienti con PD.
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of combined treatment (current L-DOPA/DDCI treatment plus opicapone 50 mg or an extra dose of 100 mg of L-DOPA) for treatment of wearing-off in PD patients.
    Valutare la sicurezza e la tollerabilità del trattamento combinato (trattamento L-DOPA/DDCI attuale più opicapone 50 mg o una dose supplementare di 100 mg di L-DOPA) per il trattamento del wearing-off in pazienti affetti da PD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria at screening (V1)
    1. Able to comprehend and willing to sign an informed consent form and to comply with all aspects of the study.
    2. Male or female patients aged 30 years or older.
    3. Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (2006) or according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria (2015).
    4. Disease severity Stages I-III (Hoehn & Yahr staging) at ON.
    5. Treated on a stable regimen for at least four weeks before screening with immediate-release L-DOPA/DDCI, three to four intakes per day, and up to maximum daily dose of 600 mg L-DOPA.
    6. In case of any other anti-PD-treatments, they should be on a stable regimen for at least four weeks before screening, and not likely to need any adjustment during the study.
    7. Signs of wearing-off phenomenon with average total daily OFF-time while awake of at least 1 hour, including the early morning pre-first dose OFF (i.e. the time between wake-up and response to the first L DOPA/DDCI dosage), despite optimal anti-PD therapy (based on
    Investigator's assessment).
    8. Experiencing wearing-off phenomenon for at least 4 weeks but less than 2 years prior to screening.
    9. For females: Postmenopausal for at least 2 years before screening, surgically sterile for at least 6 months before screening, or practicing effective contraception until the post-study visit. Female patients who request to continue with oral contraceptives must be willing to use nonhormonal methods of contraception in addition during the course of this study.

    Inclusion criteria at baseline (V2)
    10. Have filled-in self-rating diary charts in accordance with the diary chart instructions and with =3 errors per day while awake, in the three consecutive days preceding randomization.
    11. With at least 1 hour at OFF state per day, including the early morning pre-first dose OFF period (i.e. the time between wake-up and response to the first L DOPA/DDCI dosage), as recorded in at least two of the three-day self-rating diary charts for the three days preceding randomization.
    12. Adequate compliance to relevant concomitant medication during the period between V1 and V2 (based on the Investigator's judgment).
    Criteri di inclusione allo screening (Visita 1 [V1])
    1. Capacità di comprendere e volontà di firmare il modulo di consenso informato, oltre che di rispettare tutti gli aspetti dello studio.
    2. Pazienti di sesso maschile o femminile, di età uguale o superiore a 30 anni.
    3. Diagnosi di PD idiopatica secondo i Criteri diagnostici clinici della malattia di Parkinson della Brain Bank del Regno Unito (2006) o secondo i Criteri diagnostici clinici della Movement Disorder Society (MDS) (2015).
    4. Stadio dall'I al III della gravità della malattia (stadiazione clinica Hoehn-Yahr) nella fase ON.
    5. Trattamento con regime stabile per almeno quattro settimane prima dello screening con L-DOPA/DDCI a rilascio immediato, da tre a quattro assunzioni al giorno, fino alla dose giornaliera massima di 600 mg di LDOPA.
    6. In caso di qualsiasi altro trattamento anti PD, presenza di un regime stabile da almeno quattro settimane prima dello screening e probabilità di non necessitare alcuna regolazione durante lo studio.
    7. Segni di fenomeno di wearing-off con Tempo OFF medio giornaliero totale durante la veglia di almeno 1 ora, compresa il Tempo OFF mattutino precedente la prima dose (ovvero il tempo tra il risveglio e la risposta al primo dosaggio di L DOPA/DDCI), nonostante la terapia anti
    PD ottimale (in base alla valutazione dello sperimentatore).
    8. Sensazione di wearing-off per almeno quattro settimane prima dello screening e meno di due anni.
    9. Per i soggetti di sesso femminile: Post-menopausa da almeno due anni prima dello screening, chirurgicamente sterile per almeno sei mesi prima dello screening o uso di un metodo contraccettivo efficace fino alla visita post studio. Le pazienti che richiedono di continuare con
    l'assunzione di contraccettivi orali devono essere disposte a utilizzare metodi contraccettivi non ormonali aggiuntivi nel corso di questo studio.
    Criteri di inclusione al basale (Visita 2 [V2])
    10. Avere compilato i grafici di autovalutazione del diario in conformità alle relative istruzioni e con un numero di errori =3 al giorno durante la veglia, nei tre giorni consecutivi precedenti la randomizzazione.
    11. Trascorrere almeno 1 ora in stato di OFF al giorno, compreso il periodo di OFF mattutino prima della prima dose (ovvero il tempo tra il risveglio e la risposta al primo dosaggio di L DOPA/DDCI), come registrato in almeno due dei tre grafici di autovalutazione del diario per i
    tre giorni precedenti la randomizzazione.
    12. Adeguata conformità al farmaco concomitante pertinente durante il periodo tra la V1 e la V2 (sulla base del giudizio dello sperimentatore).
    E.4Principal exclusion criteria
    Exclusion criteria at screening (V1)
    1. Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
    2. Severe and/or unpredictable OFF periods, according to Investigator's judgment.
    3. Average total daily OFF-time while awake of >5 hours, including the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on Investigator's assessment).
    4. Treatment with prohibited medication: entacapone, tolcapone, monoamine oxidase (MAO) inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation, rasagiline up to 1 mg/day or safinamide up to 100 mg/day), apomorphine or antiemetics with antidopaminergic action (except domperidone) within the last 4 weeks before screening.
    5. Previous or planned (during the entire study duration) deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
    6. Previous or current use of opicapone or L-DOPA/carbidopa intestinal gel infusion.
    7. Use of any other investigational product (IP), currently or within the 3 months (or within 5 half-lives of the IP, whichever is longer) before screening.
    8. Past (within the past year) or present history of suicidal ideation or
    suicide attempts.
    9. Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine.
    10. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
    11. Known hypersensitivity to the excipients of IP (including lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption).
    12. History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis.
    13. History of severe hepatic impairment (Child-Pugh Class C).
    14. Current or previous (within the past year) diagnosis of psychosis, severe major depression or other psychiatric disorders that, based on the Investigator's judgment, might place the patient at increased risk or interfere with assessments.
    15. Any medical condition that might place the patient at increased risk or interfere with assessments.
    16. For females: Pregnant or breastfeeding.
    17. Employees of the Investigator, study centre, Sponsor, clinical research organisation and study consultants, when employees are directly involved in this study or other studies under the direction of this Investigator or study centre, and their family members.
    18. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
    Exclusion criteria at baseline (V2)
    19. With an average total daily OFF-time while awake of >5 hours, including the early morning pre-first dose OFF period (i.e. the time between wake-up and response to the first L DOPA/DDCI dosage), as recorded in at least two of the three-day self-rating diary charts for the three days preceding randomization.
    1. Paziente con diagnosi clinica di PD non idiopatica (parkinsonismo atipico, parkinsonismo secondario [acquisito o sintomatico], sindrome di Parkinson plus).
    2. Periodi OFF gravi e/o imprevedibili, secondo il giudizio dello sperimentatore.
    3. Media giornaliera totale di tempo in OFF >5 ore durante il periodo di veglia, compreso il periodo OFF mattutino precedente la prima dose, nonostante la terapia anti-PD ottimale (in base alla valutazione dello sperimentatore).
    4. Trattamento con farmaci proibiti: inibitori di entacapone, tolcapone, monoamino ossidasi (MAO) (eccetto selegilina fino a 10 mg/die nella formulazione orale o 1,25 mg/die nella formulazione di assorbimento buccale, rasagilina fino a 1 mg/die o safinamide fino a 100 mg/die),
    apomorfina o antiemetici con azione antidopaminergica (eccetto domperidone) nelle ultime quattro settimane prima dello screening.
    5. Stimolazione cerebrale profonda pregressa o pianificata (durante l'intera durata dello studio) o intervento stereotassico (ad es. pallidotomia, talamotomia).
    6. Uso pregresso o attuale di opicapone o infusione intestinale di LDOPA/ carbidopa in gel.
    7. Uso di qualsiasi altro IP, attualmente o entro i tre mesi (o entro cinque emivite dell'IP, a seconda di quale sia il periodo più lungo) prima dello screening.
    8. Anamnesi pregressa (entro lo scorso anno) o presenza di ideazione suicidaria o tentativi di suicidio.
    9. Abuso di alcol o sostanze attuale o pregresso (entro lo scorso anno), a esclusione della caffeina o nicotina.
    10. Feocromocitoma, paraganglioma o altre neoplasie che secernono catecolamina.
    11. Ipersensibilità nota agli eccipienti dell'IP (comprese l'intolleranza al lattosio o al galattosio, il deficit di Lapp lattasi o malassorbimento di glucosio-galattosio).
    12. Anamnesi di sindrome neurolettica maligna o rabdomiolisi non traumatica.
    13. Anamnesi di grave insufficienza epatica (di Classe C di Child-Pugh).
    14. Diagnosi attuale o pregressa (entro l'anno precedente) di psicosi, grave depressione maggiore o altri disturbi psichiatrici che, in base al giudizio dello sperimentatore, potrebbero esporre il paziente a rischio maggiore o interferire con le valutazioni.
    15. Qualsiasi condizione medica che potrebbe esporre il paziente a un rischio maggiore o interferire con le valutazioni.
    16. Per i soggetti di sesso femminile: Gravidanza o allattamento al seno.
    17. Dipendenti dello Sperimentatore, del centro dello studio, dello Sponsor, dell'organizzazione di ricerca clinica e dei consulenti dello studio, qualora i dipendenti siano direttamente coinvolti in questo studio o in altri studi sotto la direzione di questo Sperimentatore o centro dello
    studio, nonché i relativi familiari.
    18. Persone impegnate in un'istituzione in virtù di un ordine emesso da autorità giudiziarie o da altre autorità.
    Criteri di esclusione al basale (V2)
    19. Presenza di un tempo di OFF medio giornaliero totale >5 ore durante la veglia, compreso il periodo di OFF mattutino prima della prima dose (ovvero il tempo tra il risveglio e la risposta al primo dosaggio di L DOPA/DDCI), come registrato in almeno due delle tre griglie di autovalutazione del diario per i tre giorni precedenti la randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Absolute OFF-time from baseline to end of study
    Variazione nella durata assoluta del periodo OFF dal basale alla fine dello studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to end of study
    Dal basale alla fine dello studio
    E.5.2Secondary end point(s)
    Efficacy assessments
    • Change in Absolute OFF-time from baseline to end of study
    • Proportion of patients with one hour or more reduction in Absolute OFF-time from baseline to end of study (OFF-time responders)
    • Change in Absolute ON-time from baseline to end of study
    • Proportion of patients with one hour or more increase in Absolute ON-time from baseline to end of study (ON-time responders)
    • Change in Percentage OFF-time between baseline and end of study (calculated as the sum in minutes from 30-minute periods classified as OFF divided by the total time awake)
    • Change in Percentage ON-time between baseline and end of study (calculated as the sum in minutes from 30-minute periods classified as ON divided by the total time awake)
    • Additional efficacy outcomes include the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), the Movement Disorder Society- Non-Motor Rating Scale (MDS-NMS), the Parkinson’s Disease Questionnaire-8 (PDQ-
    8), the Clinical Global Impression of Improvement (CGI-I) and the Patient Global Impression of Change (PGI-C)
    Safety assessments
    • Adverse Events (AEs) and Serious Adverse Events (SAEs) collected from screening to the post-study follow-up visit
    Valutazioni di efficacia
    • Variazione nella durata assoluta del periodo OFF dal basale alla fine dello studio
    • Percentuale di pazienti con un'ora o più di riduzione del tempo in OFF assoluto dal basale alla fine dello studio (rispondenti Tempo OFF)
    • Variazione nella durata assoluta del periodo ON dal basale alla fine dello studio
    • Percentuale di pazienti con un'ora o più di aumento del Tempo ON assoluto dal basale alla fine dello studio (rispondenti Tempo ON)
    • Variazione nella percentuale di Tempo OFF tra il basale e la fine dello studio (calcolato come la somma in minuti da periodi di 30 minuti classificati come OFF, divisa per il tempo totale di veglia)
    • Variazione nella percentuale del Tempo ON tra il basale e la fine dello studio (calcolato come somma in minuti da periodi di 30 minuti classificati come ON, divisa per il tempo totale di veglia)
    • Ulteriori esiti di efficacia includono la Scala di valutazione della malattia di Parkinson unificata della Movement Disorder Society (MDSUPDRS), la Scala di valutazione non motoria dell'MSD (MDS-NMS), il Questionario sulla malattia di Parkinson a 8 voci (PDQ-8), l'Impressione clinica globale del miglioramento (CGI-I) e l'Impressione globale del paziente del cambiamento (PGI-C)
    Valutazioni di sicurezza
    • Eventi avversi (AE) ed eventi avversi seri (SAE) raccolti dallo screening alla visita di follow-up post-studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to end of study
    Dal basale alla fine dello studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 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 EEA25
    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
    Germany
    Italy
    Portugal
    Spain
    United Kingdom
    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 years2
    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 years2
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 100
    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)
    For a patient that terminates the study, the investigator will arrange for anti-Parkinson's treatment. No other additional care will be provided as part of the study. The patient will continue with SoC.
    Per un paziente che termina lo studio, lo sperimentatore organizzerà un trattamento anti-Parkinson. Nessun'altra assistenza aggiuntiva sarà fornita da parte dello studio. Il paziente continuerà con SoC.
    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 Decision2021-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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