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    Summary
    EudraCT Number:2019-000732-26
    Sponsor's Protocol Code Number:ExPD-ESR-18-13512
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-05-07
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-000732-26
    A.3Full title of the trial
    Effect of Exenatide on disease progression in early Parkinson's disease.
    Effekt av Exenatid på sjukdomsprogression vid tidig Parkinsons sjukdom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exenatide Treatment in Parkinson's Disease
    A.4.1Sponsor's protocol code numberExPD-ESR-18-13512
    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 SponsorStockholm Health Care Services
    B.1.3.4CountrySweden
    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 supportParkinson Reserach Foundations
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportRegion Stockholm
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportStockholm Health Care Services
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStockholm Health Care Services
    B.5.2Functional name of contact pointAcademic Specialist Center
    B.5.3 Address:
    B.5.3.1Street AddressSolnavägen 1E
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code11365
    B.5.3.4CountrySweden
    B.5.4Telephone number0046812367300
    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 Bydureon 2 mg powder and solvent for prolonged-release suspension for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameBYDUREON
    D.3.4Pharmaceutical form Powder and solvent for prolonged-release suspension for injection in pre-filled pen
    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 INNEXENATIDE
    D.3.9.1CAS number 141758-74-9
    D.3.9.4EV Substance CodeSUB21818
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for prolonged-release suspension for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's disease
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To identify the biological mechanisms that mediate Exenatide-effect in the brain, and to measure true treatment-effect of Exenatide that is independent of the concurrent, symptomatic, dopaminergic treatment.

    To evaluate the effect on motor-symptom progression. (open-label extension part one).

    To evaluate the rate and severity of AEs and the number of AEs related to long-term exposure to Exenatide(open-label extension part two).
    E.2.2Secondary objectives of the trial
    - To compare the effect of Exenatide to placebo on disease progression.
    - To compare the effect of Exenatide to placebo on motor-symptom progression.
    - To compare the effect of Exenatide to placebo on the non-motor symptom progression.
    - To measure the safety of Exenatide in patients with PD.
    - To evaluate pharmacokinetic properties of Exenatide.
    - Frequency of adverse events (open-label extension part one).
    - To evaluate changes in motor, and non-motor symptoms
    activities of daily living and complications by dopaminergic treatment (open-label extension part one and two ).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of clinically probable Parkinson’s disease.
    • Males or Females.
    • Hoehn and Yahr stage ≤ 2 in the ON medication state.
    • Patients are on levodopa treatment.
    • No need for extended treatment adjustment, no significant motor fluctuations during the last year.
    • All patients will be ≥25 and ≤80 years of age.
    • Ability to self-administer, or to arrange carer administration of the trial drug.
    • Signed informed consent to participate in the trial.
    E.4Principal exclusion criteria
    • Atypical or other causes of parkinsonism.
    • Prior intra-cerebral surgical intervention for Parkinson’s disease. Patients who have previously undergone Deep Brain Stimulation, intra-cerebral administration of growth factors, gene therapy or cell therapies will not be eligible.
    • Already actively participating in a trial of a device, drug or surgical treatment for Parkinson’s disease.
    • Previous exposure to Exenatide.
    • Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/FDG-PET acquisition.
    • Patients with body mass index less than 18.5.
    • Patients with diabetes mellitus type 1.
    • Patients with prediabetes, or T2DM.
    • History of pancreatitis.
    • Severe gastrointestinal disease including gastroparesis.
    • History of alcoholism.
    • History of severe cardiac disease.
    • History of pancreas cancer.
    • History or suspicion of thyroid cancer.
    • Personal or family history of medullary thyroid cancer.
    • Patients with Multiple Endocrine Neoplasia 2 (MEN2) syndrome.
    • End-stage renal disease or creatinine clearance < 50 ml/min.
    • Hyperlipidaemia.
    • Concurrent treatment with warfarin.
    • Concurrent severe depression, defined as MADRS score more than 16.
    • Concurrent dementia, defined as MMSE < 22.
    • Pregnancy and Breastfeeding.
    • Known hypersensitivity or allergy or intolerance to GLP-1.
    • Known hypersensitivity to Exenatide or any of its excipients.
    • Potential participants who lack the capacity to give informed consent
    • Any medical, psychiatric or other condition which in the investigator’s opinion compromises the potential participant's ability to participate in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    FDG-PET network analysis
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 9 and 21 months
    E.5.2Secondary end point(s)
    A. MDS-UPDRS part 3 in OFF-medication state and accelerometer-based parameters of physical activity, MDS-UPDRS part 3 in ON-medication state, MDS-UPDRS parts 1, 2 and 4, biofluid-based parameters

    B. LEDD

    C. PDQ-39, NMSQuest, ESS,

    D. MoCA

    E. B-SIT

    F. MADRS
    E.5.2.1Timepoint(s) of evaluation of this end point
    A. Baseline, 9, 18 and 21 months

    B. Baseline, 3, 6, 9, 12, 15, 18 and 21 months

    C. Baseline, 6, 12, 18 months

    D. Baseline, 9 and 21 months

    E. Baseline, 9 and 18 months

    F. Screening, 6, 12 and 18 months
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    A double-blind placebo-controlled trial followed by two open-label extensions, part one and part two
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    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)
    After the end of the 18-month treatment period the patients will continue on their current, symptomatic dopaminergic treatment with dose adjustments according to the clinical judgement of the investigator. After the end of the study, dopaminergic treatment will be continued and adjusted according to clinical routine.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation The Feinstein Institute for Medical Research
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-23
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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