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    Summary
    EudraCT Number:2015-000148-40
    Sponsor's Protocol Code Number:PDSTAT2015
    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:2015-09-16
    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 number2015-000148-40
    A.3Full title of the trial
    Simvastatin as a neuroprotective treatment for Parkinson's disease: a double-blind, randomised, placebo controlled futility study in patients of moderate severity.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial comparing simvastatin to placebo as a neuronal protective treatment for Parkinson's disease.
    A.3.2Name or abbreviated title of the trial where available
    Simvastatin as a neuroprotective treatment for moderate PD (PD STAT)
    A.4.1Sponsor's protocol code numberPDSTAT2015
    A.5.4Other Identifiers
    Name:REC ReferenceNumber:15/NE/0324
    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 SponsorPlymouth Hospitals NHS Trust
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPlymouth Hospitals NHS Trust
    B.5.2Functional name of contact pointVickers
    B.5.3 Address:
    B.5.3.1Street AddressResearch Office, Level 2, MSCP, Bircham Park Offices, Morlaix Drive
    B.5.3.2Town/ cityPlymouth
    B.5.3.3Post codePL6 8BQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01752432842
    B.5.5Fax number01752430919
    B.5.6E-maillisa.vickers@nhs.net
    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 Information not present in EudraCT
    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 nameSimvastatin
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSimvastatin
    D.3.9.1CAS number 79902-63-9
    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 number40
    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 placeboCapsule, soft
    D.8.4Route of administration of the placeboOral 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 18.0
    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.1.2 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 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
    To determine whether simvastatin is clearly ineffective (futile) in preventing the clinical decline of PD as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor score.
    E.2.2Secondary objectives of the trial
    To confirm the safety and tolerability of simvastatin in patients with PD.
    To distinguish symptomatic effects of simvastatin from disease modifying effects.
    To evaluate the impact of simvastatin on activities of daily living (ADL), timed motor tests, cognitive ability, mood, behaviour, non-motor symptoms (NMS) and quality of life among patients with moderate PD using standard validated tools of assessment.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    EXPERIENCE OF TRIAL PARTICIPATION SUB-STUDY:
    The aim of this sub-study (subject to securing additional funding) is to develop an understanding of the barriers and facilitators to participating in clinical trials for people living with PD.
    All participants recruited and randomised to the study will be invited to complete an ‘experience of trial participation’ survey during their involvement in the study (at baseline (following randomisation) and just prior to the 12 month and 26 month visits).
    Up to 20 participants who express an interest will be purposively selected to take part in an individual, face-to-face semi-structured interview with a researcher. The interviews will explore a variety of issues including participants’ motivation to take part in the PD STAT study, factors that made it easier (or more difficult) for them to take part, their feelings and whether their participation in this study has influenced their willingness to take part in future trials.
    Up to 10 additional semi-structured interviews will be carried out with people who volunteer to take part in the PD STAT study, but who do not fulfil the entry criteria. These interviews will focus on how the potential participant feels about this experience and the likely impact of this experience on their desire and willingness to participate in future trials.
    Up to four focus groups consisting of six to eight carers of PD STAT participants will be held. The focus groups will discuss what makes it difficult for people living with PD to participate in clinical trials and will actively seek solutions as to how these difficulties might be overcome.

    BLOOD SAMPLES FOR GENETIC ANALYSIS (OPTIONAL SUB-STUDY)
    PD STAT study participants will be provided with a separate Participant Information Sheet (PIS) for the genetics sub-study prior to the 12 month clinic visit. This will usually be posted directly to participants from the CTU at the same time as the 12 month feedback questionnaire. At the 12 month clinic visit, participants will be given an opportunity to discuss the genetics sub-study with the local study team and to have any questions answered. Those agreeing to participate in the sub-study will be asked to provide separate written informed consent. Two 10mL blood samples (approximately 2 tablespoons) will then be taken, usually at the 12 month clinic visit; one 10mL blood sample in an EDTA sample tube for the extraction of inherited material by University College London (UCL) and one 10mL blood sample in an acid citrate dextrose (ACD) sample tube for the European Consortium of Cell Cultures (ECACC), a UK based repository.
    E.3Principal inclusion criteria
    • Diagnosis of idiopathic PD
    • Modified Hoehn and Yahr stage ≤ 3.0 in the ON medication state
    • Age 40-90 years
    • On dopaminergic treatment with wearing-off phenomenon
    • Able to comply with study protocol and willing to attend necessary study visits
    E.4Principal exclusion criteria
    • Diagnosis or suspicion of other cause for parkinsonism
    • Known abnormality on CT or MRI brain imaging considered to be causing symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with study protocol
    • Concurrent dementia defined by MoCA score <21
    • Concurrent severe depression defined by MADRS score >31
    • Prior intracerebral surgical intervention for PD including deep brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplantation
    • Already actively participating in a research study that might conflict with this trial
    • Prior or current use of statins as a lipid lowering therapy
    • Intolerance to statins
    • Untreated hypothyroidism
    • End stage renal disease (creatinine clearance <30 mL/min) or history of severe cardiac disease (angina, myocardial infarction or cardiac surgery in preceding two years)
    • eGFR <30 mL/min
    • History of alcoholism or liver impairment
    • Creatine kinase (CK) >1.1 x upper limit of normal (ULN)
    • Aspartate transaminase (AST) or alanine transaminase (ALT) >1.1 x ULN
    • Females who are pregnant or breast feeding or of child-bearing potential and unwilling to use appropriate contraception methods whilst on trial treatment
    • Currently taking any medication contraindicated with simvastatin use
    • Any requirement for statin use
    • Regular participation in endurance or high-impact sports
    • Unable to abstain from consumption of grapefruit-based products
    E.5 End points
    E.5.1Primary end point(s)
    A change in MDS-UPDRS (Movement Disorder Society Unified Parkinson's disease Rating Scale) part III motor subscale score in the OFF state over 24 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months.
    E.5.2Secondary end point(s)
    - MDS-UPDRS total score in the practically defined ON state
    - MDS-UPDRS part II subscale score in the practically defined ON state
    - Timed motor tests – finger tapping and timed walk test (10MWT) in the OFF state
    - Montgomery and Asberg Depression Rating Scale (MADRS)
    - The Addenbrooke’s Cognitive Assessment-III (ACE-III)
    - Non-Motor Symptom assessment scale (NMSS)
    - Parkinson’s disease Questionnaire (PDQ-39)
    - Changes in PD medication as measured by levodopa-equivalent dose (LED)
    - Cholesterol levels (total, HDL, LDL, total/HDL ratio)
    - King’s PD pain scale (KPPS)
    - EuroQoL 5D-5L health status questionnaire (EQ-5D-5L)
    - Safety and tolerability of trial medication by adverse events (AEs) review.
    - Incidence of diabetes mellitus at 24 months (using a Glycated haemoglobin (HbA1c) level of 6.5% (48mmol/mol) as diagnostic of diabetes mellitus (WHO 2011: http://www.who.int/diabetes/publications/report-hba1c_2011.pdf)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 12 and 24 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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Futility
    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 No
    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 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 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 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 years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state198
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 198
    F.4.2.2In the whole clinical trial 198
    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)
    No treatment will be available after the trial.
    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 N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-05
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