ISRCTN14552789进行中（未招募）3 期
A randomised, double-blind, parallel-group, placebo-controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson's disease
niversity College London0 个研究点目标入组 194 人开始时间: 2019年10月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 194
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34049922/ (added 01/06/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of Parkinson’s disease. PD is a clinical diagnosis and is based on the opinion of the PI or delegate 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
- •2. 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
- •3. Between 25 and 80 years of age
- •4. On dopaminergic treatment for at least 4 weeks before enrolment. All participants must have had previous or ongoing exposure to dopaminergic treatment either as L-dopa or a dopamine agonist. If L-dopa has been stopped due to side effects or lack of response, the local PI should further confirm that the participant has clinical symptoms and signs and/or radiological investigations consistent with a diagnosis of Parkinson’s disease
- •5. Ability to self-administer, or to arrange carer administration of trial medication
- •6. Documented informed consent to participate
排除标准
- •1. Diagnosis or suspicion of other cause for Parkinsonism. Patients with clinical features indicating a diagnosis of Progressive Supranuclear Palsy, Multiple Systems Atrophy, Drug-induced Parkinsonism, Dystonic tremor or Essential tremor will not be recruited.
- •2. Patients unable to attend the clinic visits in the practically defined OFF medication state.
- •3. 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).
- •4. Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol.
- •5. Significant cognitive impairment defined by a score < 21 on the Montreal Cognitive Assessment.
- •6. Concurrent severe depression defined by a score > = 16 on the Patient Health Questionnaire (PHQ-9).
- •7. 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.
- •8. Previous participation in one of the following Parkinson’s disease trials (Biogen SPARK trial, Prothena Pasadena trial, Sanofi Genzyme MOVES-PD trial, UDCA-PD UP Study or any other trial still considered to involve a potentially PD modifying agent).
- •9. Participation in another clinical trial of a device, drug or surgical treatment within the last 30 days.
- •10. Previous exposure to exenatide.
- •11. Impaired renal function with creatinine clearance < 50 ml/min.
- •12. History of pancreatitis. Baseline serum amylase value must fall within laboratory normal range +/- 50%.
- •13. Type 1 or Type 2 Diabetes mellitus.
- •14. Severe gastrointestinal disease (e.g. gastroparesis)
- •15. 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.
- •16. History or family history of medullary thyroid cancer (MTC). Undiagnosed neck lump, hoarse voice or difficulty swallowing (not attributable to PD diagnosis).
- •17. Multiple endocrine neoplasia 2 (MEN2) syndrome.
- •18. Hypersensitivity to any of exenatide's excipients.
- •19. Females that are pregnant or breastfeeding. There are no safety data regarding Exenatide use in pregnancy.
- •20. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire trial period and up to 3 months after the last dose of trial medication. Female participants who are able to become pregnant (defined as women of childbearing potential) 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.
- •21. Participants who lack the capacity to give informed consent.
- •22. Any medical or psychiatric condition or previous conventional/experimental treatment which in the investigator’s opinion compromises the potential participant’s ability to participate.
研究者
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