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    Summary
    EudraCT Number:2018-002144-85
    Sponsor's Protocol Code Number:M15-741
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-002144-85
    A.3Full title of the trial
    A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease
    Studio clinico in aperto ed a braccio singolo della durata di 52 settimane per valutare la sicurezza e la tollerabilità dell’esposizione giornaliera di ABBV-951 somministrato per 24 ore mediante infusione sottocutanea continua in soggetti con Malattia di Parkinson.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study
    Malattia di Parkinson: Studio per valutare la sicurezza e la tollerabilità dell’esposizione giornaliera di ABBV-951 somministrato per 24 ore mediante infusione sottocutanea continua
    A.3.2Name or abbreviated title of the trial where available
    Galliarde
    Galliarde
    A.4.1Sponsor's protocol code numberM15-741
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 nameABBV-951
    D.3.2Product code [ABBV-951]
    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 INNFoslevodopa
    D.3.9.2Current sponsor codeA-1591706.0
    D.3.9.3Other descriptive nameLevodopa-4'-Monophosphate
    D.3.9.4EV Substance CodeSUB195094
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFoscarbidopa
    D.3.9.2Current sponsor codeA-1610308.0
    D.3.9.3Other descriptive nameCarbidopa-4'-Monophosphate
    D.3.9.4EV Substance CodeSUB195093
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10068100
    E.1.2Term Vascular parkinsonism
    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
    To assess the local and systemic safety and tolerability of ABBV-951 delivered as a CSCI for 24 hours daily for up to 52 weeks.
    Valutare sia a livello locale che a livello sistemico la sicurezza e la tollerabilità di ABBV-951 somministrato mediante infusione sottocutanea continua (CSCI) per 24 ore al giorno per un massimo di 52 settimane
    E.2.2Secondary objectives of the trial
    To assess the efficacy of ABBV-951 as measured by patient-reported and rater-measured efficacy endpoints.
    Valutare l’efficacia di ABBV-951 misurata in base a endpoint di efficacia riferiti dai pazienti e misurati da un servizio di valutazione centralizzato
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult male or female subjects, 30 years of age or older at the time of screening, with a diagnosis of idiopathic PD that is levodopa-responsive
    Soggetti adulti di ambo i sessi, di età pari o superiore a 30 anni al momento dello screening, con una diagnosi di malattia di Parkinson idiopatica che è responsiva alla levodopa
    E.4Principal exclusion criteria
    Subjects judged by the investigator to be adequately controlled by current therapy, that don't have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have less than 2.5 hours of "Off" time per day.
    Soggetti che lo sperimentatore considera essere controllati in maniera adeguata dalla terapia in corso, che non hanno fasi “Off” e “On” riconoscibili/identificabili (fluttuazioni motorie) e che sono in fase “off” per meno di 2,5 ore al giorno.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of subjects with adverse events (AEs) and serious adverse events (SAEs) during the study
    2. Percentage of subjects with AEs of special interest (AESI) during the study
    3. Percentage of subjects with numeric grade equal to or higher than 5 and percentage of subjects with letter grade equal to or higher than D on the Infusion Site Evaluation Scale at any time during the study
    4. Change in clinical laboratory test data from Baseline to end of study
    5. Change in vital sign measurements from Baseline to end of study
    6. Change in electrocardiograms (ECGs) from Baseline to end of study
    1. Percentuale di soggetti che presentano eventi avversi (AE) e eventi avversi seri (SAE) nel corso dello studio
    2. Percentuale di soggetti con AE di interesse speciale (AESI) nel corso dello studio
    3. Percentuale di soggetti con punteggio numerico pari o superiore a 5 e percentuale di soggetti con punteggio alfabetico pari o superiore a D alla scala di valutazione del sito di infusione (Infusion Site Evaluation Scale) in qualsiasi momento nel corso dello studio
    4. Variazione rispetto al Baseline dei dati relativi alle analisi di laboratorio rilevati alla fine dello studio
    5. Variazione rispetto al Baseline dei parametri dei segni vitali rilevati alla fine dello studio
    6. Variazione rispetto al Baseline dei parametri elettrocardiografici (ECG) rilevati alla fine dello studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Screening Visit 1, Enrollment Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, Week 52/Premature Discontinuation, Unscheduled visits.
    2. Screening Visit 1, Enrollment Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, Week 52/Premature Discontinuation, Unscheduled visits.
    3. Enrollment Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, Week 52/Premature Discontinuation, Unscheduled visits.
    4. Enrollment Day 1, Week 6, Week 26, Week 39, Week 52/Premature Discontinuation.
    5. Enrollment Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, Week 52/Premature Discontinuation, Unscheduled visits.
    6. Enrollment Day 1, Week 6, Week 52/Premature Discontinuation.
    1.SV 1, Arruolamento Giorno 1, Giorno 2, Sett 1, Sett 2, Sett 3, Sett 4, Sett 6, Sett 13, Sett 26, Sett 39, Sett 52/Interruzione Anticipata, visite non programmate
    2.SV 1, Arruolamento Giorno 1, Giorno 2, Sett 1, Sett 2, Sett 3, Sett 4, Sett 6, Sett 13, Sett 26, Sett 39, Sett 52/Interruzione Anticipata, visite non programmate
    3.Arruolamento Giorno 1, Giorno 2, Sett 1, Sett 2, Sett 3, Sett 4, Sett 6, Sett 13, Sett 26, Sett 39, Sett 52/Interruzione Anticipata, visite non programmate
    4.Arruolamento Giorno 1, Sett 6, Sett 26, Sett 39, Sett 52/Interruzione Anticipata
    5.Arruolamento Giorno 1, Giorno 2, Sett 1, Sett 2, Sett 3, Sett 4, Sett 6, Sett 13, Sett 26, Sett 39, Sett 52/Interruzione Anticipata, visite non programmate
    6.Arruolamento Giorno 1, Sett 6, Sett 52/Interruzione Anticipata
    E.5.2Secondary end point(s)
    Change from Baseline to end of study for the following:
    1. Average normalized daily "Off" time and "On" times as assessed by the PD Diary
    2. PD symptoms as assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV (or the UPDRS Parts I-V in countries where a validated translation of the MDS-UPDRS is
    not available)
    3. Sleep symptoms as assessed by the PD Sleep Scale-2 (PDSS-2)
    4. Quality of life as assessed by the PD Questionnaire-39 items (PDQ-39)
    5. Health-related quality of life as assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L)
    Variazione rispetto al Baseline dei seguenti parametri rilevati alla fine dello studio:
    1. Media normalizzata giornaliera del tempo “OFF” e del tempo “ON” valutata in base al diario della malattia di Parkinson
    2. Sintomi della malattia di Parkinson valutati in base alla scala MDS-UPDRS (Movement Disorder Society-Unified Parkinson’s Disease Rating Scale) Parti I-IV (oppure UPDRS Parti I-V nelle nazioni dove non sia disponibile una traduzione validata della scala MDS-UPDRS)
    3. Sintomi relativi al sonno valutati in base alla scala PDSS_2 (PD Sleep Scale)
    4. Qualità di vita valutati in base al questionario PDQ-39 (PD Questionnaire-39 items)
    5. Qualità di vita correlata alla salute, valutata in base al questionario EQ-5D-5L (EuroQol 5-dimensions)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Enrollment Day 1 (V3), Week 1 (V5), Week 6 (V9), Week 26 (V11), Week 39 (V12), Week 52 (V13)/Premature Discontinuation
    2. Enrollment Day 1 (V3), Day 2 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 4 (V8), Week 6 (V9), Week 13 (V10), Week 26 (V11), Week 39 (V12), Week 52 (V13)/Premature Discontinuation
    3. Enrollment Day 1 (V3), Week 6 (V9), Week 13 (V10), Week 26 (V11), Week 39 (V12), Week 52 (V13)/Premature Discontinuation
    4. Enrollment Day 1 (V3), Week 6 (V9), Week 13 (V10), Week 26 (V11), Week 39 (V12), Week 52 (V13)/Premature Discontinuation
    5. Enrollment Day 1 (V3), Week 6 (V9), Week 13 (V10), Week 26 (V11), Week 39 (V12), Week 52 (V13)/Premature Discontinuation
    1. Arruolamento Giorno 1 (V3), Sett 1 (V5), Sett 6 (V9), Sett 26 (V11), Sett 39 (V12), Sett 52 (V13)/Interruzione Anticipata
    2. Arruolamento Giorno 1 (V3), Giorno 2 (V4), Sett 1 (V5), Sett 2(V6), Sett 3 (V7), Sett 4 (V8), Settimana 6 (V9), Settimana 13 (V10), Settimana 26 (V11), Settimana 39 (V12), Settimana 52 (V13)/Interruzione Anticipata
    3. Arruolamento Giorno 1 (V3), Settimana 6 (V9), Settimana 13 (V10), Settimana 26 (V11), Settimana 39 (V12), Settimana 52 (V13)/Interruzione Anticipata
    4. Arruolamento Giorno 1 (V3), Settimana 6 (V9), Settimana 13 (V10), Settimana 26 (V11), Settimana 39 (V12), Settimana 52 (V13)/Interruzione Anticipata
    5. Arruolamento Giorno 1 (V3), Settimana 6 (V9), Settimana 13 (V10), Settimana 26 (V11), Settimana 39 (V12), Settimana 52 (V13)/Interruzione Anticipata
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open: Yes
    na
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Australia
    Canada
    Japan
    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
    LSLV
    LSLV
    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 months3
    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 months3
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 130
    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)
    Active subjects randomized to ABBV-951, subjects will continue on study treatment throughout the study for a period of up to 52 weeks or until premature discontinuation of study drug. At study completion, subjects may transition to a 24-hour CSCI of ABBV-951 open-label extension study.
    Soggetti attivi randomizzati a ricevere ABBV-951: i soggetti continueranno a ricevere il trattamento sperimentale durante l’intero corso dello studio per un periodo massimo di 52 settimane oppure fino al momento dell’interruzione anticipata del medicinale sperimentale. Alla conclusione dello studio clinico, i soggetti potrebbero entrare nello studio di estensione in aperto che prevede la somministrazione 24 ore al giorno di ABBV-951 mediante infusione sottocutanea continua (CSCI)
    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 Decision2019-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-17
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