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    Summary
    EudraCT Number:2016-002454-20
    Sponsor's Protocol Code Number:35RC15_9724
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-16
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-002454-20
    A.3Full title of the trial
    Apomorphine Pump in Early Stage of Parkinson’s Disease
    Pompe à apomorphine au stade précoce de la maladie de Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Apomorphine Pump in Early Stage of Parkinson’s Disease
    Pompe à apomorphine au stade précoce de la maladie de Parkinson
    A.3.2Name or abbreviated title of the trial where available
    EARLY-PUMP
    EARLY-PUMP
    A.4.1Sponsor's protocol code number35RC15_9724
    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 SponsorCHU de Rennes
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCHU de Rennes
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Rennes
    B.5.2Functional name of contact pointLEROYER
    B.5.3 Address:
    B.5.3.1Street Address2 rue Henri Le Guilloux
    B.5.3.2Town/ cityRENNES
    B.5.3.3Post code35033
    B.5.3.4CountryFrance
    B.5.4Telephone number33299 28 97 47
    B.5.5Fax number33299 28 37 22
    B.5.6E-maildrc@chu-rennes.fr
    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 APOKINON
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE AGUETTANT
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAPOKINON
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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
    Maladie de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson’s disease
    Maladie de 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 19.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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
    The primary objective of the trial is to investigate the impact on the QoL of the apomorphine pump (APO group) compared to conventional optimized oral therapy (Control group) in earlier stages of PD, when motor complications have just developed
    Déterminer l’impact sur la qualité de vie de la pompe à apomorphine (Groupe APO), en comparaison au traitement oral conventionnel optimisé (Groupe Contrôle), à un stade précoce de la maladie de Parkinson, alors que les complications motrices commencent juste à se développer
    E.2.2Secondary objectives of the trial
    •To assess the impact on motor and non-motor impairment of the APO group vs Control group;
    •To assess the impact on personal, social and professional functioning for the APO group vs Control group;
    •To investigate the safety and tolerability of the apomorphine pump vs conventional optimized oral therapy.
    •To determine apomorphine pump-related cost- effectiveness compared to conventional optimized oral treatment at 24 months from the French National Health Insurance perspective.
    - Comparer l’impact sur les symptômes moteurs et non moteurs entre le groupe APO et le groupe Contrôle,
    - Comparer l’impact sur les fonctionnements personnel, social et professionnel entre le groupe APO et le groupe Contrôle,
    - Comparer la tolérance et la sécurité d’emploi entre le groupe APO et le groupe Contrôle,
    - Démontrer que l’utilisation de la pompe à apomorphine est une approche efficiente (en terme économique) à deux ans, dans le contexte de la prise en charge de la maladie de Parkinson à un stade précoce, en comparaison au traitement médicamenteux oral optimisé, du point de vue de l’assurance maladie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults aged ≤ 65 years,
    - Idiopathic PD (According to British Brain Bank Criteria) without any other known or suspected cause of Parkinsonism,
    - Hoehn and Yahr stage ≤ 2.5 in the best ON,
    - Disease duration ≥ 4 years,
    - Presence of fluctuations and/or dyskinesia for no more than 3 years,
    - One of the two following forms of impairment:
    * Impairment in activities of daily living (MDS-UPDRS II>6) due to PD-symptoms despite medical treatment in the worst condition or
    * Impairment of social and occupational functioning (measured with SOFAS) due to PD-symptoms despite medical treatment (51-80%),
    - PDQ39 completed,
    - Able to understand and remember the components of the study,
    - Written informed consent,
    - Patients covered with social insurance.
    - Adultes ≤ 65 ans,
    - Maladie de Parkinson idiopathique (selon les critères British Brain Bank) sans autre cause connue ou suspectée de parkinsonisme,
    - Stade Hoehn et Yahr ≤ 2.5 au best ON,
    - Durée de la maladie ≥ 4 ans,
    - Présence de fluctuation et/ou de dyskinésies depuis moins de 3 ans,
    - Une des deux altérations suivantes :
    * Altération dans les activités de la vie quotidienne (MDS-UPDRS II>6) due aux symptômes de la maladie de Parkinson, malgré le traitement médical optimisé,
    * Altération du fonctionnement social (mesuré par l’échelle SOFAS) dûe aux symptômes de la maladie de Parkinson, malgré le traitement médical (51-80%),
    - PDQ39 initiale complétée,
    - Capacité de comprendre le protocole,
    - Consentement libre et éclairé,
    - Patient couvert par un système d'assurance sociale.
    E.4Principal exclusion criteria
    - Dementia (MoCA score < 22),
    - Major uncontrolled depression at the time of assessment (BDI > 25) or Bipolar disease
    - Active Hallucinations or history of hallucinations in the past year
    - Need for nursing care,
    - Previous use of apomorphine pump treatment,
    - History of respiratory depression
    - History of deep brain stimulation or lesional surgery for PD or intrajejunal L-Dopa,
    - Presence of severe freezing or clinically relevant postural instability leading to falls during the ON state,
    -Symptomatic clinically relevant and medically uncontrolled orthostatic hypotension,
    - Clinically relevant hepatic dysfunction (total bilirubin >2.0 mg/dL, ALT and AST >2 times the upper limit of normal)
    - Clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL),
    - Pregnant and breastfeeding women,
    - Hypersensitivity to apomorphine or any excipients of the medicinal product,
    - Concomitant therapy or within 28 days prior to baseline with : alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except Clozapine) , methylphenidate, or amphetamine, intrajejunal Ldopa
    - History or current drug or alcohol abuse or dependencies,
    - Patients with a borderline QT interval corrected for heart rate according to Bazett’s formula (QTc) of >450 ms for male and >470 ms for female at screening or history of long QTsyndrome; or >450 ms absolute duration,
    - Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty.
    - Démence (MoCA score < 22),
    - Episode dépressif majeur, non contrôlé au moment de l’évaluation (BDI > 25) ou trouble bipolaire,
    - Hallucinations actives ou antécédents d’hallucinations l’année précédente,
    - Nécessité de soins infirmiers,
    - Utilisation antérieure de la pompe à apomorphine,
    - Antécédent de dépression respiratoire,
    - Antécédent de Stimulation Cérébrale Profonde ou de chirurgie lésionnelle pour la maladie de Parkinson ou d’utilisation intra jéjunale de L-DOPA,
    - Présence de Freezing sévère ou d’instabilité posturale cliniquement significative engendrant des chutes, en état ON,
    - Hypotension orthostatique symptomatiquement et médicalement incontrôlée,
    - Dysfonction hépatique cliniquement significative (bilirubine totale >2.0 mg/dL, ALAT et ASAT >2 fois la limite supérieure de la normale ),
    - Insuffisance rénale cliniquement significative (créatinine sérique >2.0 mg/dL),
    - Femmes enceintes ou allaitantes,
    - Allergie à l’apomorphine ou à un des excipients du médicament expérimental,
    - Traitement en cours ou ayant été pris 28 jours avant l’inclusion par : alpha-methyl dopa, metoclopramide, reserpine, neuroleptiques (hors Clozapine), methylphenidate, ou amphetamine, intrajejunal Ldopa,
    - Antécédent, usage actuel ou dépendance à la drogue ou à l’alcool,
    - Patients avec Intervalle QT limite, corrigé pour le rythme cardiaque selon la formule de Bazett (QTc) soit un QTc > à 450 ms pour les hommes et > à 470 ms pour les femmes au moment du screening, ou tout antécédent de syndrome du QT long ou > à 450 ms de durée absolue;
    - Incapables majeurs (sauvegarde de justice, curatelle et tutelle) et les personnes privées de liberté.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the difference in the PDQ39 summary index between the baseline assessment and the assessment at 12 months’ follow up. The two treatment groups (APO vs Control) will be compared.
    Le critère de jugement principal est l’évolution du score à l’échelle PDQ39 entre l’entrée dans l’étude et la visite à 12 mois. Les deux groups (APO et contrôle) seront comparés.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months' follow up
    M12
    E.5.2Secondary end point(s)
    1- Patient Global Impression of Change (PGIC)
    2- Neurologist Global Impression of change (CGI-I)
    3- Change in Non-Motor Aspects of Experiences of Daily Living (MDS-UPDRS I)
    4- Change in Motor Aspects of Experiences of Daily Living in “on” and “off” medication (MDS-UPDRS II)
    5- Change in motor examination during “on” periods (MDS-UPDRS III)
    6- Change in motor complications with MDS-UPDRS IV
    7- Patient diaries:
     Change in the number of hours per day in the “best ON” state
     Change in the number of hours per day in ON with dyskinesia
     Change in the number of hours per day in OFF state
     Sleeping-hours per day
    8- Change in Score of the Non-Motor Symptoms Scale for PD (NMSS)
    9- Change in psychosocial functioning PD (SCOPA-PS)
    10- Changes in mood and occurrence and characteristics of depressive symptoms (BDI)
    11- Change in occurrence of anxiety (STAI-S)
    12 -Change in Score of VAS
    13- Change in cognitive function: Montreal Cognitive Assessment (MoCA); Free and cued selective reminding test (FCSRT), 10/36 Spatial Recall Test (SPART), Digit Symbol Modalities test (SDMT), Digit Span, Letter-Number Sequencing Test (OTMT), Color Word Interference Test (CWIT), Benton judgement of line orientation test, Clock drawing test, Boston naming test short version, and semantic verbal fluency constituting the overall neuropsychological evaluation
    14- Change in apathy (Apathy Scale and short version of LARS)
    15- Change in medication (L-DOPA equivalents)
    16- The safety endpoints:
     Frequency and intensity of behavioral symptoms (Ardouin Scale)
     Frequency, type and severity of therapy-related adverse events
     Skin changes
     Full blood count
     Epworth Sleepiness Scale
    17- - Incremental Cost-Effectiveness Ratio (ICER) at 24 months following inclusion defined as (Average costs in “APO group” – average costs in “Control group”) / (average QALYs in “APO group”-average QALYs in “Control group”) to determine the cost for one QALY gained in the “APO group” versus “Control group”.
    1- Impression clinique globale de changement du patient (Patient Global Impression of Change (PGIC)),
    2- Impression clinique globale de changement du neurologue (Neurologist Global Impression of change (CGI-I)),
    3- Changement des symptômes non moteurs dans la vie quotidienne (MDS-UPDRS I),
    4- Changement des symptômes moteurs dans la vie quotidienne (MDS-UPDRS II),
    5- Changement de l’examen moteur en période “on” (MDS-UPDRS III),
    6- Changement des complications motrices (MDS-UPDRS IV),
    7- Recueil journalier:
     Nombre d’heures par jour passées en état “ON”,
     Nombre d’heures par jour passées en état de dyskinésies,
     Nombre d’heures par jour passées en état “OFF”,
     Nombre d’heures de sommeil par jour,
    8- Changement dans les fluctuations non motrices (NMSS),
    9- Changement dans le fonctionnement psychosocial (SCOPA-PS),
    10- Changement en terme d’humeur et d’apparition de symptômes dépressifs (BDI),
    11- Changement en terme d’anxiété (STAI-S),
    12- Changement en terme de douleur,
    13- Changement en terme de fonctionnement cognitif : Montreal Cognitive Assessment (MoCA); Free and cued selective reminding test (FCSRT), 10/36 Spatial Recall Test (SPART), Digit Symbol Modalities test (SDMT), Digit Span, Letter-Number Sequencing Test (OTMT), Color Word Interference Test (CWIT), Benton judgement of line orientation test, Clock drawing test, Boston naming test short version, et semantic verbal fluency,
    14- Changement en terme d’apathie (échelle d’Apathie et version courte de la LARS),
    15- Changement en terme de traitements (équivalents L-DOPA),
    16- Tolérance:
     Fréquence et intensité des symptômes non moteurs comportementaux (échelle d’Ardouin),
     Fréquence, type et sévérité des évènements indésirables jugés en lien avec la thérapeutique utilisée,
     Modifications cutanées,
     NFS,
     Echelle de sommeil d’Epworth,
    17- Ratio coût-efficacité incremental (Cost-effectiveness Ratio, ICER) à 2 ans exprimé en coût par QALY (Quality Adjusted Life Year) gagné dans le groupe APO, par rapport au groupe Contrôle.

    E.5.2.1Timepoint(s) of evaluation of this end point
    1 / 12 months' follow up
    2 / 12 months' follow up
    3 / 12 months' follow up
    4 / 12 months' follow up
    5 / 12 months' follow up
    6 / 12 months' follow up
    7 / 12 months' follow up
    8 / 12 months' follow up
    9 / 12 months' follow up
    10 / 12 months' follow up
    11 / 12 months' follow up
    12 / 12 months' follow up
    13 / 12 months' follow up
    14 / 12 months' follow up
    15 / 12 months' follow up
    16/ 12 months' follow up
    17 / 24 months' follow up
    1-M12
    2-M12
    3-M12
    4-M12
    5-M12
    6-M12
    7-M12
    8-M12
    9-M12
    10-M12
    11-M12
    12-M12
    13-M12
    14-M12
    15-M12
    16-M12
    17-M24
    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 Yes
    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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Traitement médical optimisé
    Best Medical Treatment (BMT)
    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 concerned21
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    24 months after the last inclusion
    24 mois après la dernière inclusion
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 192
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state192
    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)
    None
    Aucun
    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 Decision2016-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
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