A randomised, double-blind, placebo-controlled, single-centre, 60-week trial of Exenatide once weekly for the treatment of moderate severity Parkinson's disease

niversity College London (UK)0 个研究点目标入组 60 人开始时间: 2014年1月24日最近更新: 2018年6月18日

适应症

试验速览

•1. Diagnosis of Parkinson's disease
•2. Males or females
•3. Hoehn and Yahr stage = 2.5 in the on medication state
•4. Between 25 and 75 years of age
•5. On dopaminergic treatment with wearing off phenomena
•6. Ability to self-administer, or to arrange carer administration of trial drug
•7. Documented informed consent to participate

•1. Diagnosis or suspicion of other cause for Parkinsonism. Subject without DaTscan appearances consistent with diagnosis of PD will not be eligible
•2. Body mass index <18.5
•3. Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/DaTSCAN acquisition
•4. Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale
•5. Concurrent severe depression defined by a score >16 on the MADRS
•6. Prior intra-cerebral surgical intervention for Parkinson's disease
•7. Already actively participating in a trial of a device, drug or surgical treatment for Parkinson's disease
•8. Previous exposure to Exenatide
•9. Severely impaired renal function with creatinine clearance <30 ml/min
•10. History of pancreatitis
•11. Severe gastrointestinal disease (e.g., gastroparesis)
•12. Hyperlipidaemia
•13. History or suspicion of thyroid cancer
•14. Known or suspected intolerance of DaTSCAN or Potassium Iodide administration
•15. Females that are pregnant or breast feeding. Women of childbearing potential 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
•16. Participants who lack the capacity to give informed consent
•17. Any medical or psychiatric condition which in the investigator's opinion compromises the potential participant's ability to participate

发起方

niversity College London (UK)