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    Summary
    EudraCT Number:2014-004865-26
    Sponsor's Protocol Code Number:M12-927
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-15
    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 ConcernedSpain - AEMPS
    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
    Estudio aleatorizado y abierto, para comparar durante 26 semanas el efecto del tratamiento con gel intestinal de levodopa-carbidopa (GILC) y del tratamiento médico óptimo (TMO) sobre los síntomas no motores (SNM) en pacientes con enfermedad de Parkinson avanzada ? Estudio 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
    Estudio de 26 semanas que compara el gel intestinal Levodopa-Carbidopa con el tratamiento médico óptimo sobre los síntomas no motores en pacientes con enfermedad de Parkinson avanzada
    A.3.2Name or abbreviated title of the trial where available
    INSIGHTS Study
    Estudio 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+34901 20 01 03
    B.5.5Fax number+441628644330
    B.5.6E-mailabbvie_reec@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 AuthorisationEuropean Union
    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
    Síntomas no motores en pacientes con enfermedad de Parkinson avanzada
    E.1.1.1Medical condition in easily understood language
    Advanced Parkinson's disease
    Enfermedad de Parkinson avanzada
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    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.
    El objetivo principal del estudio es evaluar el efecto del GILC, en comparación con el TMO, sobre los síntomas no motores de la enfermedad de Parkinson avanzada
    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.
    Evaluar el efecto del GILC, en comparación con el TMO, sobre los síntomas y complicaciones motoras, la seguridad, la tolerabilidad y los criterios de valoración relacionados con la salud
    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. Los pacientes deben tener una puntuación total como mínimo de 20 en la PDSS-2 en la evaluación basal.
    2. Los pacientes deben tener un diagnóstico de enfermedad de Parkinson idiopática conforme a los criterios del United Kingdom Parkinson?s Disease Society (UKPDS). Véanse los criterios de la UKPDS en el apéndice C.
    3. Los pacientes deben presentar fluctuaciones motoras persistentes a pesar del tratamiento óptimo personalizado.
    4. Presentar enfermedad de Parkinson sensible a levodopa.
    5. El paciente ha recibido tratamiento óptimo con los antiparkinsonianos disponibles y el control de los síntomas motores conseguido con él se considera insuficiente. Por tratamiento óptimo se entiende el tratamiento farmacológico con el que se obtiene el máximo efecto terapéutico, de manera que ya no se prevé conseguir más mejoría aunque se modifique la administración de levodopa o de otros antiparkinsonianos. Será el investigador quien determine, según su criterio clínico, si se ha alcanzado el tratamiento óptimo.
    6. El paciente o cuando proceda, su cuidador, debe ser capaz de rellenar el diario de administración del paciente y de manejar, manipular y cuidar la bomba de infusión y la sonda.
    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. El diagnóstico de enfermedad de Parkinson es dudoso o se sospecha que el paciente presenta un síndrome parkinsoniano, como parkinsonismo secundario (por ejemplo, por fármacos, toxinas, agentes infecciosos, enfermedad vascular, traumatismo, neoplasia cerebral), síndrome de Parkinson plus (por ejemplo, atrofia multisistémica, parálisis supranuclear progresiva, enfermedad difusa con cuerpos de Lewy) u otra enfermedad neurodegenerativa que pudiera imitar los síntomas de la enfermedad de Parkinson.
    2. El paciente se ha sometido a una intervención neuroquirúrgica para el tratamiento de la enfermedad de Parkinson.
    3. El paciente presenta algún déficit neurológico que pudiera interferir en las evaluaciones del estudio (por ejemplo, hemiparesia).
    4. Conocimiento de hipersensibilidad a levodopa, carbidopa, o material radiopaco.
    5. El paciente presenta alguna contraindicación al tratamiento con levodopa (por ejemplo, glaucoma de ángulo estrecho, melanoma maligno).
    6. El paciente ha presentado, en algún momento durante los tres meses precedentes a la selección, crisis de sueño o conductas impulsivas (por ejemplo, ludopatía, hipersexualidad) de importancia clínica, según criterio del investigador.
    7. El paciente ha recibido apomorfina en infusión continua para el tratamiento de la enfermedad de 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.
    Puntuación total de la escala de síntomas no motores (NMSS) y la escala modificada del sueño en la enfermedad de Parkinson (PDSS-2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 6, Week 12, Week 26
    Evaluación basal, semana 6, semana 12 y semana 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)
    ? 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
    Se medirá la escala unificada de valoración de la enfermedad de Parkinson (UPDRS), partes III y IV.

    La seguridad y la tolerabilidad se evaluarán mediante lo siguiente:
    ? Vigilancia de los acontecimientos adversos.
    ? Exploración neurológica
    ? Evaluación analítica
    ? Electrocardiograma
    ? Constantes vitales y peso
    ? Escala de valoración del riesgo de suicidio de la Universidad de Columbia (C-SSRS)
    ? Entrevista de Minnesota para los trastornos impulsivos (MIDI)
    ? Cuestionario sobre crisis de sueño (SAQ)

    Los criterios de valoración relacionados con la salud se evaluarán mediante las escalas siguientes:
    ? Cuestionario de calidad de vida en la enfermedad de Parkinson de ocho apartados (PDQ-8)
    ? Escala de impresión clínica global de cambio (CGI-C)
    ? UPDRS, partes I y II
    ? Cuestionario de impresión global de cambio según el paciente (PGIC)
    ? Escala de ansiedad en la enfermedad de Parkinson (PAS)
    ? Escala de depresión geriátrica (GDS-15)
    ? Escala de dolor en la enfermedad de Parkinson (EP) del King's College Hospital
    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
    UPDRS partes III y IV: Pre-selección, evaluación basal, semana 6, semana 12 y semana 26.
    Seguridad y tolerabilidad: en cada visita
    HEOR: evaluación basal, semana 6, semana 12 y semana 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 concerned7
    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
    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 state42
    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.
    Los pacientes asignados aleatoriamente al tratamiento con GILC podrán continuar con el tratamiento con el producto comercial. Los pacientes asignados aleatoriamente en el tratamiento con TMO serán elegibles para ser tratados con GILC comercial. Todo tratamiento comercial se proporcionará a través del programa comercial y el reembolso del seguro de cada país
    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 Decision2015-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
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