Simvastatin as a neuroprotective treatment for Parkinson’s disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study
dc.contributor.author | Carroll, Camille | |
dc.contributor.author | Webb, D | |
dc.contributor.author | Stevens , KN | |
dc.contributor.author | Vickery, Jane | |
dc.contributor.author | Eyre, V | |
dc.contributor.author | Ball, S | |
dc.contributor.author | Wyse, R | |
dc.contributor.author | Webber, M | |
dc.contributor.author | Foggo, Andrew | |
dc.contributor.author | Zajicek, J | |
dc.contributor.author | Whone, A | |
dc.contributor.author | Creanor, Siobhan | |
dc.date.accessioned | 2019-10-03T11:04:43Z | |
dc.date.issued | 2019-10-07 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.other | ARTN e029740 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/14959 | |
dc.description.abstract |
<jats:sec><jats:title>Introduction</jats:title><jats:p>Parkinson’s disease (PD) is a progressive neurodegenerative condition affecting approximately 185,000 people in the UK. No drug has been proven to slow disease progression. Epidemiological and pre-clinical data support simvastatin, a widely used cholesterol-lowering drug with a well-established safety profile, having neuroprotective properties. The aim of this study (Simvastatin as a neuroprotective treatment for PD (PD STAT)) is to determine whether simvastatin has the potential to slow PD progression. The study is part of the International Linked Clinical Trials initiative coordinated by The Cure Parkinson’s Trust. This paper describes the protocol for the PD STAT study.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>PD STAT is a double-blind, randomised, placebo-controlled, multi-centre, parallel group, futility trial in patients with PD of mild–moderate severity. 235 participants have been recruited and randomly allocated in a 1:1 ratio to receive either oral simvastatin or matched placebo. Treatment involves a 1-month low-dose phase (40 mg daily), followed by a 23-month high-dose phase (80 mg daily) and ends with a 2-month washout period. Participants are reviewed at clinic visits at 1 month, 6, 12, 18, 24 and 26 months post-baseline, with interim telephone follow-up to monitor for adverse events.</jats:p><jats:p>The primary outcome is the change in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale part III motor subscale score in the practically defined OFF medication state (OFF state) between baseline and 24 months. Primary analysis will be on a modified intention to treat basis and will include only those participants who progress to the high-dose phase of the study.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The protocol has been approved by the North East–Newcastle and North Tyneside 2 Research Ethics Committee. The results will be disseminated via research articles in peer-reviewed journals and presentations at local, national and international scientific meetings, as well as disseminated via patient groups, websites and networks. A summary of the study findings will be posted to participants at the end of the study.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="isrctn" xlink:href="ISRCTN16108482">ISRCTN16108482</jats:ext-link>(prospectively registered); EudraCT 2015-000148-40; ClinicalTrials.gov<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT02787590" specific-use="clinicaltrial pre-results">NCT02787590</jats:ext-link>; Pre-results.</jats:p></jats:sec> | |
dc.format.extent | e029740-e029740 | |
dc.format.medium | Electronic | |
dc.language | en | |
dc.language.iso | en | |
dc.publisher | BMJ Publishing Group | |
dc.subject | MDS-UPDRS | |
dc.subject | Parkinson’s disease | |
dc.subject | neuroprotective effect | |
dc.subject | randomised controlled futility study | |
dc.subject | statin | |
dc.subject | Disease Progression | |
dc.subject | Dose-Response Relationship, Drug | |
dc.subject | Double-Blind Method | |
dc.subject | Drug Monitoring | |
dc.subject | Drug-Related Side Effects and Adverse Reactions | |
dc.subject | Female | |
dc.subject | Humans | |
dc.subject | Interviews as Topic | |
dc.subject | Male | |
dc.subject | Middle Aged | |
dc.subject | Neurologic Examination | |
dc.subject | Neuroprotective Agents | |
dc.subject | Outcome Assessment, Health Care | |
dc.subject | Parkinson Disease | |
dc.subject | Randomized Controlled Trials as Topic | |
dc.subject | Simvastatin | |
dc.title | Simvastatin as a neuroprotective treatment for Parkinson’s disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study | |
dc.type | journal-article | |
dc.type | Clinical Trial Protocol | |
dc.type | Journal Article | |
dc.type | Research Support, Non-U.S. Gov't | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000512882200100&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 10 | |
plymouth.volume | 9 | |
plymouth.publication-status | Published | |
plymouth.journal | BMJ Open | |
dc.identifier.doi | 10.1136/bmjopen-2019-029740 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/Peninsula Medical School | |
plymouth.organisational-group | /Plymouth/Faculty of Science and Engineering | |
plymouth.organisational-group | /Plymouth/Faculty of Science and Engineering/School of Biological and Marine Sciences | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA07 Earth Systems and Environmental Sciences | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/FoH - Applied Parkinson's Research | |
plymouth.organisational-group | /Plymouth/Research Groups/FoH - Community and Primary Care | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Health and Community | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED) | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBBB | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS | |
plymouth.organisational-group | /Plymouth/Research Groups/Marine Institute | |
plymouth.organisational-group | /Plymouth/Research Groups/Plymouth Institute of Health and Care Research (PIHR) | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
dc.publisher.place | England | |
dcterms.dateAccepted | 2019-08-19 | |
dc.rights.embargodate | 2019-11-27 | |
dc.identifier.eissn | 2044-6055 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1136/bmjopen-2019-029740 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2019-10-07 | |
rioxxterms.type | Journal Article/Review |