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    Summary
    EudraCT Number:2013-003363-64
    Sponsor's Protocol Code Number:13/0384
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-003363-64
    A.3Full title of the trial
    A randomised, double blind, placebo controlled, single centre, 60 week trial of Exenatide once weekly for the treatment of moderate severity Parkinson’s disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial of Exenatide for Parkinson's disease
    A.3.2Name or abbreviated title of the trial where available
    Exenatide-PD
    A.4.1Sponsor's protocol code number13/0384
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN75891427
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01971242
    A.5.4Other Identifiers
    Name:FoxTrialFinderNumber:Exenatide-pd
    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 SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    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 supportMichael J Fox Foundation for Parkinson's Research
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College London Clinical Trials Unit
    B.5.2Functional name of contact pointGuilherme Schroeter
    B.5.3 Address:
    B.5.3.1Street AddressUCL Clinical Trials Unit, Gower Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1E6BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02076796348
    B.5.6E-mailguy.schroeter@ucl.ac.uk
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameExenatide
    D.3.4Pharmaceutical form Powder and solvent for prolonged-release suspension 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 INNexenatide
    D.3.9.1CAS number 141732-76-5
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This trial aims to generate further data to explore whether 48 weeks exposure to Exenatide has an advantage over placebo based on a standard validated assessment of Parkinson's disease severity (the MDS UPDRS part 3 motor subscale). This will be measured during the “practically defined OFF medication state” i.e. after patients have withheld their conventional PD medication overnight. The hypothesis is that Exenatide will be associated with reduced MDS UPDRS part 3 scores at the study end.
    E.2.2Secondary objectives of the trial
    To further examine the safety and tolerability of 48 weeks exposure to Exenatide in patients with moderate severity PD.

    To collect Pharmacokinetic data regarding the degree of penetration of Exenatide across the blood brain barrier. We hypothesise that any central effects of Exenatide will be mediated through penetration of Exenatide across the blood brain barrier. Data obtained from rodents suggests that blood brain barrier penetration is excellent.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of Parkinson’s disease. PD is a clinical diagnosis and is based on the opinion of the PI on site after review of the clinical history, examination findings and response to PD medication. The Queen Square brain bank criteria MAY be used to help assist in the diagnosis although this need not be a formal inclusion criteria, and the relevance of a positive family history of PD, or a confirmed genetic basis for an individual’s symptoms will be evaluated in the context of other clinical features in determining diagnosis and eligibility. Alternative possible diagnoses such as “Dystonic tremor”, “Essential tremor”, “Progressive Supranuclear palsy”, “Multiple Systems Atrophy” will be specifically considered during screening prior to randomisation.

    Males or Females.

    Hoehn and Yahr stage ≤ 2.5 in the On medication state. This implies that all patients will be mobile without assistance during their best “On” medication periods.

    All patients will be ≥25 and ≤75 years of age.

    On dopaminergic treatment with wearing off phenomena. All patients must have had previous or ongoing exposure to L-dopa. If L-dopa has been stopped due to side effects, patients must report an improvement in symptom control with other forms of dopaminergic treatment. Wearing off will be determined according to the history supplied by the patient that their symptom control fluctuates according to the timing of their dopaminergic therapy.
    E.4Principal exclusion criteria
    Diagnosis or suspicion of other cause for Parkinsonism. Patients with clinical features indicating a diagnosis of Progressive Supranuclear Palsy, Multiple Systems Atrophy, and Drug induced Parkinsonism, Dystonic tremor or Essential tremor will not be recruited. Subjects without DaTscan appearances consistent with diagnosis of PD will not be eligible.

    Body mass index <18.5. (Exenatide is known to cause weight loss therefore individuals that may not tolerate further weight loss will not be recruited).

    Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/DaTSCAN acquisition.

    Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale. Although Exenatide may have positive effects on cognition, for the purposes of this trial, patients with dementia will be excluded.

    Concurrent severe depression defined by a score >16 on the MADRS.

    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.

    Severely impaired renal function with creatinine clearance <30ml/min.

    Hyperlipidaemia. A lipid profile will be tested at the screening visit. Cholesterol or Triglyceride levels greater than 2 x the upper limit of normal will raise suspicion of a familial or acquired hyperlipidaemia and will prompt referral to a relevant specialist for investigation and treatment.

    History of pancreatitis. Baseline serum amylase value must fall within laboratory normal range +/- 20%.

    Severe gastrointestinal disease (e.g. gastroparesis).

    History or suspicion of thyroid cancer. Undiagnosed neck lump, hoarse voice or difficulty swallowing (not attributable to PD diagnosis).
    Known or suspected intolerance of DaTSCAN or Potassium Iodide administration.

    Females that are pregnant or breast feeding. There are no safety data regarding Exenatide use in pregnancy. Female participants who are able to become pregnant (defined as women of child bearing potential; see section 4, Glossary) will undergo a pregnancy test prior to randomisation and will be asked at each visit to confirm regular use of an effective method of contraception (see section 4, Glossary). WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
    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 fully
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to compare the effectiveness of Exenatide versus placebo on the MDS UPDRS part 3 motor subscale in the “practically defined OFF medication state” in patients with moderate severity PD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be assessed on the MDS UPDRS part 3 motor subscale at baseline and then at the 60 week visit and the scores compared.
    E.5.2Secondary end point(s)
    Secondary objectives are to
    Compare differences at 48 and 60 weeks between the Exenatide and placebo trial arms in:
    • Movement Disorder Society Unified Parkinson’s Disease Rating Scale part 3 Motor subsection Off medication score at 48 weeks.
    • Movement Disorder Society Unified Parkinson’s Disease Rating Scale part 1,2,3 and 4 On medication scores
    • Mattis Dementia Rating scale (DRS-2)
    • Safety and tolerability of Exenatide as indicated by changes in Vital signs, weight, clinical laboratory measures and Adverse Effects
    E.5.2.1Timepoint(s) of evaluation of this end point
    All assessments will be performed at the 48 week and 60 week visit and the scoreds compared.
    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 No
    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) 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 No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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: 0
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Once the trial has finished, any further treatment will be given as per standard care, at the discretion of the treating clinician. No further trial drug will be given.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-12
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