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    Summary
    EudraCT Number:2014-004865-26
    Sponsor's Protocol Code Number:M12-927
    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:2015-05-29
    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 number2014-004865-26
    A.3Full title of the trial
    An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study
    “Sperimentazione in Aperto, Randomizzata, della durata di 26 Settimane, per Valutare gli Effetti di Levodopa-Carbidopa Gel Intestinale (LCIG) Rispetto al Trattamento Medico Ottimizzato (Optimized Medical Treatment, OMT) sui Sintomi Non-Motori (NMS) in Soggetti con Malattia di Parkinson in Fase Avanzata – Studio INSIGHTS”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease
    “Sperimentazione della durata di 26 Settimane, per Valutare gli Effetti di Levodopa-Carbidopa Gel Intestinale rispetto al Trattamento Medico Ottimizzato sui Sintomi Non-Motori in Soggetti con Malattia di Parkinson in Fase Avanzata”
    A.3.2Name or abbreviated title of the trial where available
    INSIGHTS Study
    Studio INSIGHTS
    A.4.1Sponsor's protocol code numberM12-927
    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 AddressAbbott House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628773355
    B.5.5Fax number+441628644330
    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 Yes
    D.2.1.1.1Trade name Duodopa
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/01/035
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Intestinal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral 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.3.9.3Other descriptive nameLEVODOPA
    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 number20
    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.3.9.3Other descriptive nameCARBIDOPA MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21619
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Non-motor symptoms in advanced Parkinson's disease
    Sintomi non motori nella malattia di Parkinson in fase avanzata
    E.1.1.1Medical condition in easily understood language
    Advanced Parkinson's disease
    Malattia di Parkinson in fase avanzata
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to examine the effect of LCIG relative to that of OMT on non motor symptoms associated with advanced Parkinson's disease.
    L’obiettivo primario di questa sperimentazione è valutare l’effetto del trattamento con LCIG rispetto al trattamento medico ottimizzato (OMT) sui sintomi non motori che si associano alla Malattia di Parkinson (MP) in fase avanzata.
    E.2.2Secondary objectives of the trial
    To assess the effect of LCIG relative to that of OMT on the motor symptoms/motor complications, safety, tolerability and health-related outcome measures.
    Valutare gli effetti del trattamento con LCIG rispetto a OMT sui parametri relativi a: sintomi motori/complicanze motorie, sicurezza, tollerabilità ed esiti correlati alla salute.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must have a minimum PDSS-2 total score of 20 at Baseline assessment.
    2. Subject must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria. See Appendix C for UKPDS.
    3. Subject demonstrates persistent motor fluctuations in spite of individually optimized treatment.
    4. The subject's Parkinson's disease is levodopa-responsive.
    5. Subject has had optimal treatment with available anti-PD medication and their motor symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of levodopa and/or other antiparkinsonian medication. This will be based on the Investigator's clinical judgment.
    6. Subject and/or if applicable, their care-partner must be able to complete the Subject Dosing Diary and must be able to demonstrate the ability to operate, manipulate and care for the infusion pump and tubing.
    1) Soggetto con un punteggio totale PDSS-2 pari ad almeno 20 alla valutazione eseguita al Baseline;
    2) Il soggetto deve avere una diagnosi di malattia di Parkinson idiopatica secondo i criteri Brain Bank UKPDS (United Kingdom Parkinson’s Diseases Society).Vedere Appendice C per UKPDS;
    3) Soggetto che dimostra fluttuazioni motorie persistenti nonostante l’ottimizzazione del trattamento personalizzato;
    4) Soggetto con malattia di Parkinson responsivo alla levodopa;
    5) Soggetto i cui sintomi motori non sono risultati controllati in maniera adeguata dal trattamento ottimizzato con i farmaci antiparkinson disponibili. Per trattamento ottimizzato si intende l’effetto terapeutico massimo ottenuto con le terapie farmacologiche antiparkinson, quando non sono attesi ulteriori miglioramenti indipendentemente da qualsiasi ulteriore aggiustamento della levodopa e/o di altri farmaci antiparkinson. Tale valutazione si baserà sul giudizio clinico dello sperimentatore; 6) Soggetto e/o, se applicabile, caregiver in grado di compilare il Diario di Somministrazione del Soggetto e di dimostrare la propria capacità di operare, maneggiare ed avere cura della pompa per infusione e dei sondini.

    E.4Principal exclusion criteria
    1. Subject's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g., Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD.
    2. Subject has undergone neurosurgery for the treatment of Parkinson's disease.
    3. Subject has any neurological deficit that might interfere with the study assessments (e.g., hemiparesis).
    4. Known hypersensitivity to levodopa, carbidopa or radiopaque material.
    5. Subject has contraindications to levodopa, (e.g., narrow angle glaucoma, malignant melanoma).
    6. Subject experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g., pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation) as judged by the Principal Investigator.
    7.Subject has undergone apomorphine continuous infusion for the treatment of Parkinson's disease
    1) Soggetti la cui diagnosi di Malattia di Parkinson non è chiara o per cui si sospetti una sindrome parkinsoniana quali parkinsonismo secondario (es., indotto da farmaci, tossine, agenti infettivi, vasculopatia, trauma, neoplasie cerebrali), sindrome Parkinson Plus (es, Atrofia Sistemica Multipla, Paralisi Sopranucleare Progressiva, Malattia a Corpi di Lewy Diffusi) o altre patologie neurodegenerative che mimano i sintomi di Parkinson;
    2) Soggetti sottoposti a intervento neurochirurgico per il trattamento della malattia di Parkinson;
    3) Soggetti con qualsiasi deficit neurologico in che interferisca con le valutazioni previste per la sperimentazione (es., emiparesi);
    4) Nota ipersensibilità a levodopa, carbidopa o a materiale radiopaco
    5) Soggetti che presentano controindicazioni alla levodopa (es., glaucoma ad angolo stretto, melanoma maligno)
    6) Soggetti che presentano colpi di sonno oppure comportamento impulsivo (es., gioco d’azzardo patologico, ipersessualità) considerati clinicamente significativi dallo Sperimentatore Principale in qualsiasi momento nei tre mesi precedenti le valutazioni dello Screening;
    7) Soggetti che hanno ricevuto infusione continua di apomorfina per il trattamento della malattia di Parkinson
    E.5 End points
    E.5.1Primary end point(s)
    Non-Motor Symptoms Scale (NMSS) Total Score and the Modified Parkinson's Disease Sleep Scale (PDSS-2) Total Score.
    Punteggio totale della scala NMSS (Non-Motor Symptoms Scale) e punteggio totale della scala modificata PDSS-2 (Modified Parkinson’s Disease Sleep Scale).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 6, Week 12, Week 26
    Basale, Settimana 6, Settimana 12, Settimana 26
    E.5.2Secondary end point(s)
    Motor symptoms/motor complications will be measured by •Unified Parkinson's Disease Rating Scale (UPDRS) Parts III and IV

    Safety and tolerability will be assessed by:
    • Adverse event monitoring
    • Neurological exams
    • Clinical laboratory evaluations
    • Electrocardiogram
    • Vital signs and weight
    • Columbia Suicide Severity Rating Scale (C-SSRS)
    • Minnesota Impulsive Disorders Interview (MIDI)
    ‚óŹ Sleep Attacks Questionnaire (SAQ)

    Health Related Outcomes will be measured by:
    • Parkinson's Disease Questionaire-8 (PDQ-8)
    • Clinical Global Impression of Change (CGI-C)
    • UPDRS Parts I and II
    • Patient Global Impression of Change (PGIC)
    • Montreal Cognitive Assessment Test (MOCA)
    • PD Anxiety Index (PAS)
    • Geriatric Depression Scale (GDS-15)
    • King PD Pain Scale
    Sintomi motori/complicanze motorie saranno valutati mediante:
    •Scala UPDRS (Unified Parkinson’s Disease Rating Scale), Parti III e IV
    Sicurezza e tollerabilità saranno valutate mediante:
    •Monitoraggio degli eventi avversi
    •Esami neurologici
    •Analisi cliniche di laboratorio
    •Elettrocardiogramma
    •Segni vitali e peso
    •Scala C-SSRS (Columbia Suicide Severity Rating Scale)
    •MIDI (Minnesota Impulsive Disorders Interview)
    •SAQ (Sleep Attacks Questionnaire)
    Gli esiti correlati alla salute saranno misurati in base ai seguenti parametri:
    •Questionario PDQ-8 (Parkinson’s Disease Questionnaire-8)
    •Scala CGI-C (Clinical Global Impression of Change)
    •Scala UPDRS, Parti I e II
    •Scala PGIC (Patient Global Impression of Change)
    •Scala MOCA (Montreal Cognitive Assessment Test)
    •Scala PAS (Parkinson Anxiety Scale)
    •Scala GDS-15 (Geriatric Depression Scale)
    •Scala King’s relativa al dolore associato alla Malattia di Parkinson
    E.5.2.1Timepoint(s) of evaluation of this end point
    UPDRS Parts III and IV:Screening, Baseline, Week6, Week 12, Week 26
    Safety and Tolerability: every visit
    HEOR: Baseline, Week 6, Week 12, Week 26
    Scala UPDRS (Unified Parkinson’s Disease Rating Scale), Parts III and IV: Screening, Basale, Settimana 6, Settimana 12, Settimana 26
    Sicurezza e Tollerabilità: ogni visita
    HEOR (Health Economics and Outcomes Research): Basale, Settimana 6, Settimana 12, Settimana 26
    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 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) No
    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 EEA22
    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 No
    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
    European Union
    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
    LPLV
    LPLV
    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 months5
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days26
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 65
    F.4.2.2In the whole clinical trial 88
    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)
    Subjects randomized to the LCIG treatment arm will be able to continue the treatment via commercial product. Subjects randomized in the OMT arm will be eligible for commercial LCIG. All commercial treatment will be provided through the local country's commercial program and local insurance reimbursement.
    I soggetti randomizzati nel braccio LCIG avranno la possibilità di continuare il trattamento con il farmaco commerciale. I soggetti randomizzati nel braccio OMT saranno eliggibili a passare al trattamento con il farmaco commerciale LCIG. Tutti i trattamenti con farmaco commerciale saranno rimborsati seguendo le normali procedure locali.
    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 Decision2015-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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