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    Summary
    EudraCT Number:2019-004235-23
    Sponsor's Protocol Code Number:M15-737
    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:2020-10-22
    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 number2019-004235-23
    A.3Full title of the trial
    An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease.
    Estensione in aperto dello Studio clinico M15-741 per valutare la sicurezza e la tollerabilità dell’esposizione giornaliera di 24 ore ad ABBV-951 somministrato 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: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.
    Malattia di Parkinson: Una estensione dello Studio M15-741 per valutare la sicurezza e la tollerabilità di ABBV-951 in soggetti affetti da malattia di Parkinson.
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberM15-737
    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 nameFoscarbidopa and Foslevodopa
    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 CodeSUB201845
    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.3.11 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 continued
    ABBV-951 treatment delivered as a CSCI for 24 hours daily.
    Valutare la sicurezza e la tollerabilità locale e sistemica del trattamento continuato con ABBV-951 erogato mediante CSCI per 24 ore al giorno
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be able to understand the nature of the study and have had the opportunity to have any questions answered by the investigator.
    2. Subject, if judged by the investigator to have decision making capacity, must voluntarily sign and date an informed consent form approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to initiation of any study-specific procedures.
    3. Subject completed ABBV-951 Study M15-741 (parent study).
    4. Subject is willing and able to comply with procedures required in this protocol.
    5. Subject is not considered by the investigator to be an unsuitable candidate to continue to receive ABBV-951 for any reason.
    6. Subject confirms to not have suicidal ideation (as evidenced by answering "no" to Questions 4 or 5 on the suicidal ideation portion of the C-SSRS) at the Final Visit of the parent study.
    7. If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least 1 protocol-specified method of birth control that is effective from D1 through at least 30 days after the end of the infusion of study drug. Subject is not pregnant, breastfeeding, or considering becoming pregnant or donating eggs during the study or within 30 days after the end of the infusion of study drug. If female of childbearing potential, subject must have a negative urine pregnancy test on D1.
    8. If male and sexually active with a female partner(s) of childbearing potential, subject must agree to practice protocol-specified contraception. Subject is not considering fathering a child or donating sperm during the study or within 30 days after the end of the infusion of study drug.
    1. Il soggetto deve essere in grado di comprendere la natura dello studio e deve aver avuto l’opportunità di ottenere dal medico sperimentatore una risposta alle proprie domande.
    2. Il soggetto, purché il medico sperimentatore lo consideri in grado di prendere decisioni, deve volontariamente firmare e datare un modulo di consenso informato approvato da un comitato etico indipendente, prima dell’inizio di qualsiasi procedura specifica per lo studio.
    3. Il soggetto ha completato lo Studio M15-741 con ABBV-951 (studio originario).
    4. Il soggetto è disponibile e in grado di attenersi alle procedure richieste da questo protocollo.
    5. Il soggetto non è considerato dallo sperimentatore come non idoneo per qualsiasi motivo a continuare a ricevere ABBV-951
    6. Il soggetto conferma di non avere ideazione suicidaria (come confermato dall’aver risposto “no” alle Domande 4 o 5 nella sezione relativa all’ideazione suicidaria del questionario C-SSRS) in occasione della Visita Finale dello studio originario.
    7. Se di sesso femminile, il soggetto deve essere in menopausa OPPURE essere chirurgicamente sterile in maniera permanente OPPURE se in età fertile, deve utilizzare almeno un metodo contraccettivo fra quelli specificati dal protocollo che sia efficace a partire dal Giorno 1 fino ad almeno 30 giorni dopo la fine dell’infusione del medicinale sperimentale. Il soggetto di sesso femminile non deve essere in stato di gravidanza, non deve allattare al seno o non deve pianificare l’inizio di una gravidanza o la donazione di ovociti nel corso dello studio o nei 30 giorni successivi alla fine dell’infusione del medicinale sperimentale. Se di sesso femminile e in età fertile, il soggetto deve avere un risultato negativo al test di gravidanza su urine eseguito il Giorno 1.
    8. Se di sesso maschile e sessualmente attivo con uno o più partner in età fertile, il soggetto deve acconsentire ad utilizzare la contraccezione specificato dal protocollo. Il soggetto non deve avere l’intenzione di procreare con la sua partner oppure di donare sperma nel corso dello studio o nei 30 giorni successivi alla fine dell’infusione del medicinale sperimentale
    E.4Principal exclusion criteria
    1. Subject has received an investigational product other than ABBV-951 within a time period equal to 5 half-lives, if known, or within 6 weeks, whichever is longer, prior to study drug administration.
    1. Il soggetto ha ricevuto un prodotto sperimentale diverso da ABBV-951 entro un periodo di tempo equivalente a 5 emivite , se conosciuto , oppure entro 6 settimane, quale dei due periodi sia più lungo, prima della somministrazione del medicinale sperimentale
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of subjects with adverse events (AEs) and SAEs during the study
    2. Percentage of subjects with AEs of special interest (AESIs) 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 the end of study
    5. Change in vital sign measurements from Baseline to the end of study
    6. Change in electrocardiograms (ECGs) from Baseline to the end of study
    1. Percentuale di soggetti con eventi avversi (AE) e SAE durante lo studio
    2. Percentuale di soggetti con AE di interesse speciale (AESI) durante lo studio
    3. Percentuale di soggetti con un giudizio numerico uguale o maggiore di 5 e percentuale di soggetti con un giudizio in lettere uguale o maggiore di D sulla Scala di Valutazione del Sito di Infusione in qualsiasi momento durante lo studio
    4. Variazione rispetto al Baseline dei parametri clinici di laboratorio valutata alla fine dello studio
    5. Variazione rispetto al Baseline dei segni vitali valutata alla fine dello studio
    6. Variazione rispetto al Baseline degli elettrocardiogrammi dal Baseline rilevata alla fine dello studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At each remote assessment and clinic visit.
    2. At each remote assessment and clinic visit
    3. Collected at each clinic visit
    4. Collected at each clinic visit
    5. Collected at each clinic visit
    6. Collected at each clinic visit
    1. In occasione di ogni valutazione in remoto e visita presso il centro
    2. In occasione di ogni valutazione in remoto e visita presso il centro
    3. Raccolto a ciascuna visita presso il centro
    4. Raccolto a ciascuna visita presso il centro
    5. Raccolto a ciascuna visita presso il centro
    6. Raccolto a ciascuna visita presso il centro
    E.5.2Secondary end point(s)
    Change from Baseline to the 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
    3. Quality of life as assessed by the PD Questionnaire-39 items (PDQ-39)
    4. Health-related quality of life as assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L)
    5. Cognitive impairment as assessed by the Mini-Mental State Examination (MMSE)
    Variazione rispetto al Baseline e rilevata alla fine dello studio dei seguenti parametri:
    1. Medie normalizzate dei periodi giornalieri “Off” e “On” valutati dal diario della malattia di Parkinson
    2. Sintomi della malattia di Parkinson valutati dalle parti I-IV della scala di valutazione Movement Disorder Society-Unified Parkinson’s Disease (MDS-UPDRS)
    3. Qualità di vita valutata dalla scala PD Questionnaire-39 items (PDQ-39)
    4. Qualità di vita relativa alla salute valutata dal questionario EuroQol 5-dimension (EQ-5D-5L)
    5. Compromissione cognitiva valutata mediante Mini-Mental State Examination (MMSE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints are collected at each clinic visit.
    Tutti gli endpoint secondari vengono raccolti a ciascuna visita presso il centro
    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) 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 No
    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 EEA27
    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
    Russian Federation
    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
    The end-of-study is defined as the date of the last subject's last visit or date of the last follow-up contact, whichever is later.
    La fine dello studio è definita quale la data dell’ultima visita dell’ultimo soggetto oppure la data dell’ultimo contatto di follow-up, quale dei due avvenga per ultimo
    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 months0
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days18
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 80
    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)
    There is no continued treatment expected after the end of the trial. It is expected the treatment will be available commercially or the subject would resume oral therapy.
    Non si prevede alcuna continuazione del trattamento dopo la fine dello studio. Si prevede che il trattamento sarà disponibile in commercio o che il soggetto riprenderà la terapia orale
    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 Decision2020-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
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