Exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson’s disease: protocol for a multicentre, randomised, double blind, parallel group, placebo controlled, phase 3 trial: The ‘Exenatide-PD3’ study
IntroductionParkinson’s disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The glucagon like peptide-1 receptor agonist exenatide has been associated in single-centre studies with reduced motor deterioration over 1 year. T...
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| Published in | BMJ open Vol. 11; no. 5; p. e047993 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London
British Medical Journal Publishing Group
28.05.2021
BMJ Publishing Group LTD BMJ Publishing Group |
| Series | Protocol |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2044-6055 2044-6055 |
| DOI | 10.1136/bmjopen-2020-047993 |
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| Abstract | IntroductionParkinson’s disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The glucagon like peptide-1 receptor agonist exenatide has been associated in single-centre studies with reduced motor deterioration over 1 year. The aim of this multicentre UK trial is to confirm whether these previous positive results are maintained in a larger number of participants over 2 years and if effects accumulate with prolonged drug exposure.Methods and analysisThis is a phase 3, multicentre, double-blind, randomised, placebo-controlled trial of exenatide at a dose of 2 mg weekly in 200 participants with mild to moderate PD. Treatment duration is 96 weeks. Randomisation is 1:1, drug to placebo. Assessments are performed at baseline, week 12, 24, 36, 48, 60, 72, 84 and 96 weeks.The primary outcome is the comparison of Movement Disorders Society Unified Parkinson’s Disease Rating Scale part 3 motor subscore in the practically defined OFF medication state at 96 weeks between participants according to treatment allocation. Secondary outcomes will compare the change between groups among other motor, non-motor and cognitive scores. The primary outcome will be reported using descriptive statistics and comparisons between treatment groups using a mixed model, adjusting for baseline scores. Secondary outcomes will be summarised between treatment groups using summary statistics and appropriate statistical tests to assess for significant differences.Ethics and disseminationThis trial has been approved by the South Central-Berkshire Research Ethics Committee and the Health Research Authority. Results will be disseminated in peer-reviewed journals, presented at scientific meetings and to patients in lay-summary format.Trial registration numbersNCT04232969, ISRCTN14552789. |
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| AbstractList | IntroductionParkinson’s disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The glucagon like peptide-1 receptor agonist exenatide has been associated in single-centre studies with reduced motor deterioration over 1 year. The aim of this multicentre UK trial is to confirm whether these previous positive results are maintained in a larger number of participants over 2 years and if effects accumulate with prolonged drug exposure.Methods and analysisThis is a phase 3, multicentre, double-blind, randomised, placebo-controlled trial of exenatide at a dose of 2 mg weekly in 200 participants with mild to moderate PD. Treatment duration is 96 weeks. Randomisation is 1:1, drug to placebo. Assessments are performed at baseline, week 12, 24, 36, 48, 60, 72, 84 and 96 weeks.The primary outcome is the comparison of Movement Disorders Society Unified Parkinson’s Disease Rating Scale part 3 motor subscore in the practically defined OFF medication state at 96 weeks between participants according to treatment allocation. Secondary outcomes will compare the change between groups among other motor, non-motor and cognitive scores. The primary outcome will be reported using descriptive statistics and comparisons between treatment groups using a mixed model, adjusting for baseline scores. Secondary outcomes will be summarised between treatment groups using summary statistics and appropriate statistical tests to assess for significant differences.Ethics and disseminationThis trial has been approved by the South Central-Berkshire Research Ethics Committee and the Health Research Authority. Results will be disseminated in peer-reviewed journals, presented at scientific meetings and to patients in lay-summary format.Trial registration numbersNCT04232969, ISRCTN14552789. Introduction Parkinson’s disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The glucagon like peptide-1 receptor agonist exenatide has been associated in single-centre studies with reduced motor deterioration over 1 year. The aim of this multicentre UK trial is to confirm whether these previous positive results are maintained in a larger number of participants over 2 years and if effects accumulate with prolonged drug exposure.Methods and analysis This is a phase 3, multicentre, double-blind, randomised, placebo-controlled trial of exenatide at a dose of 2 mg weekly in 200 participants with mild to moderate PD. Treatment duration is 96 weeks. Randomisation is 1:1, drug to placebo. Assessments are performed at baseline, week 12, 24, 36, 48, 60, 72, 84 and 96 weeks.The primary outcome is the comparison of Movement Disorders Society Unified Parkinson’s Disease Rating Scale part 3 motor subscore in the practically defined OFF medication state at 96 weeks between participants according to treatment allocation. Secondary outcomes will compare the change between groups among other motor, non-motor and cognitive scores. The primary outcome will be reported using descriptive statistics and comparisons between treatment groups using a mixed model, adjusting for baseline scores. Secondary outcomes will be summarised between treatment groups using summary statistics and appropriate statistical tests to assess for significant differences.Ethics and dissemination This trial has been approved by the South Central-Berkshire Research Ethics Committee and the Health Research Authority. Results will be disseminated in peer-reviewed journals, presented at scientific meetings and to patients in lay-summary format.Trial registration numbers NCT04232969, ISRCTN14552789. Parkinson's disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The glucagon like peptide-1 receptor agonist exenatide has been associated in single-centre studies with reduced motor deterioration over 1 year. The aim of this multicentre UK trial is to confirm whether these previous positive results are maintained in a larger number of participants over 2 years and if effects accumulate with prolonged drug exposure.INTRODUCTIONParkinson's disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The glucagon like peptide-1 receptor agonist exenatide has been associated in single-centre studies with reduced motor deterioration over 1 year. The aim of this multicentre UK trial is to confirm whether these previous positive results are maintained in a larger number of participants over 2 years and if effects accumulate with prolonged drug exposure.This is a phase 3, multicentre, double-blind, randomised, placebo-controlled trial of exenatide at a dose of 2 mg weekly in 200 participants with mild to moderate PD. Treatment duration is 96 weeks. Randomisation is 1:1, drug to placebo. Assessments are performed at baseline, week 12, 24, 36, 48, 60, 72, 84 and 96 weeks.The primary outcome is the comparison of Movement Disorders Society Unified Parkinson's Disease Rating Scale part 3 motor subscore in the practically defined OFF medication state at 96 weeks between participants according to treatment allocation. Secondary outcomes will compare the change between groups among other motor, non-motor and cognitive scores. The primary outcome will be reported using descriptive statistics and comparisons between treatment groups using a mixed model, adjusting for baseline scores. Secondary outcomes will be summarised between treatment groups using summary statistics and appropriate statistical tests to assess for significant differences.METHODS AND ANALYSISThis is a phase 3, multicentre, double-blind, randomised, placebo-controlled trial of exenatide at a dose of 2 mg weekly in 200 participants with mild to moderate PD. Treatment duration is 96 weeks. Randomisation is 1:1, drug to placebo. Assessments are performed at baseline, week 12, 24, 36, 48, 60, 72, 84 and 96 weeks.The primary outcome is the comparison of Movement Disorders Society Unified Parkinson's Disease Rating Scale part 3 motor subscore in the practically defined OFF medication state at 96 weeks between participants according to treatment allocation. Secondary outcomes will compare the change between groups among other motor, non-motor and cognitive scores. The primary outcome will be reported using descriptive statistics and comparisons between treatment groups using a mixed model, adjusting for baseline scores. Secondary outcomes will be summarised between treatment groups using summary statistics and appropriate statistical tests to assess for significant differences.This trial has been approved by the South Central-Berkshire Research Ethics Committee and the Health Research Authority. Results will be disseminated in peer-reviewed journals, presented at scientific meetings and to patients in lay-summary format.ETHICS AND DISSEMINATIONThis trial has been approved by the South Central-Berkshire Research Ethics Committee and the Health Research Authority. Results will be disseminated in peer-reviewed journals, presented at scientific meetings and to patients in lay-summary format.NCT04232969, ISRCTN14552789.TRIAL REGISTRATION NUMBERSNCT04232969, ISRCTN14552789. |
| Author | Carroll, Camille B Vijiaratnam, Nirosen Morris, Huw Hibbert, Steve Athauda, Dilan Silverdale, Monty Chau, Marisa King, Alexa Rochester, Lynn Duncan, Gordon W Dickson, John Girges, Christine Chaudhuri, Ray Auld, Grace Hunter, Rachael Del Din, Silvia Chowdhury, Kashfia Lo, Christine Skene, Simon Maclagan, Kate Hu, Michele T Gibson, Rachel Foltynie, Thomas Limousin, Patricia Libri, Vincenzo Yarnall, Alison J |
| AuthorAffiliation | 16 Newcastle Upon Tyne NHS Foundation Trust , Newcastle , UK 11 Department of Neurology and Neurosurgery , University of Manchester , Greater Manchester , UK 2 National Hospital for Neurology and Neurosurgery , London , UK 6 Applied Parkinson's Research Group , University of Plymouth , Plymouth , UK 12 Western General Hospital , NHS Lothian , Edinburgh , UK 13 University of Edinburgh , Edinburgh , UK 1 Department of Clinical and Movement Neurosciences , UCL Queen Square Institute of Neurology , London , UK 4 Surrey Clinical Trials Unit , University of Surrey , Guildford , UK 9 Oxford Parkinson's Disease Centre , University of Oxford , Oxford , UK 15 Translational & Clinical Research Institute , Newcastle University , Newcastle upon Tyne , UK 17 London , UK 19 Research Dept of Primary Care and Population Health , University College London , London , UK 7 University Hospitals Plymouth NHS Trust , Plymouth , UK 10 Department of Clinical Neurology , Oxford University Hospitals NHS Foundation Trust , Ox |
| AuthorAffiliation_xml | – name: 20 Leonard Wolfson Experimental Neurology Centre , National Hospital for Neurology & Neurosurgery , London , UK – name: 15 Translational & Clinical Research Institute , Newcastle University , Newcastle upon Tyne , UK – name: 7 University Hospitals Plymouth NHS Trust , Plymouth , UK – name: 8 Nuffield Department of Clinical Neurosciences , University of Oxford , Oxford , Oxfordshire , UK – name: 13 University of Edinburgh , Edinburgh , UK – name: 1 Department of Clinical and Movement Neurosciences , UCL Queen Square Institute of Neurology , London , UK – name: 2 National Hospital for Neurology and Neurosurgery , London , UK – name: 5 Department of Clinical & Experimental Medicine , University of Surrey , Guildford , UK – name: 6 Applied Parkinson's Research Group , University of Plymouth , Plymouth , UK – name: 4 Surrey Clinical Trials Unit , University of Surrey , Guildford , UK – name: 18 Department of Nuclear Medicine , University College London Hopsitals NHS Trust , London , UK – name: 21 University College London , London , UK – name: 14 Parkinson's Foundation International Centre of Excellence , King\'s College London , London , UK – name: 11 Department of Neurology and Neurosurgery , University of Manchester , Greater Manchester , UK – name: 10 Department of Clinical Neurology , Oxford University Hospitals NHS Foundation Trust , Oxford , UK – name: 17 London , UK – name: 19 Research Dept of Primary Care and Population Health , University College London , London , UK – name: 16 Newcastle Upon Tyne NHS Foundation Trust , Newcastle , UK – name: 3 The Comprehensive Clinical Trials Unit , UCL , London , UK – name: 9 Oxford Parkinson's Disease Centre , University of Oxford , Oxford , UK – name: 12 Western General Hospital , NHS Lothian , Edinburgh , UK |
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| Snippet | IntroductionParkinson’s disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The... Parkinson's disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The glucagon like... Introduction Parkinson’s disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The... |
| SourceID | doaj pubmedcentral proquest crossref bmj |
| SourceType | Open Website Open Access Repository Aggregation Database Enrichment Source Index Database Publisher |
| StartPage | e047993 |
| SubjectTerms | Diabetes Dopamine Double-blind studies Dyskinesia GLP-1 receptor agonists Laboratories Movement disorders Neurology Parkinson's disease Patients Performance evaluation Public health Qualitative research Questionnaires Society |
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| Title | Exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson’s disease: protocol for a multicentre, randomised, double blind, parallel group, placebo controlled, phase 3 trial: The ‘Exenatide-PD3’ study |
| URI | https://bmjopen.bmj.com/content/11/5/e047993.full https://www.proquest.com/docview/2533649064 https://www.proquest.com/docview/2534615953 https://pubmed.ncbi.nlm.nih.gov/PMC8166598 https://doaj.org/article/747e573c62344e5b81c9220c10131898 |
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