EUCTR2013-003363-64-GB进行中（未招募）1 期
A randomised, double blind, placebo controlled, single centre, 60 week trial of Exenatide once weekly for the treatment of moderate severity Parkinson’s disease. - Exenatide-PD
niversity College London0 个研究点目标入组 60 人开始时间: 2014年3月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Diagnosis of Parkinson’s disease. PD is a clinical diagnosis and is based on the opinion of the PI 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. Alternative possible diagnoses such as Dystonic tremor”, Essential tremor”, Progressive Supranuclear palsy”, Multiple Systems Atrophy” will be specifically considered during screening prior to randomisation.
- •Males or Females.
- •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.
- •All patients will be =25 and =75 years of age.
- •On dopaminergic treatment with wearing off phenomena. All patients must have had previous or ongoing exposure to L-dopa. If L-dopa has been stopped due to side effects, patients must report an improvement in symptom control with other forms of dopaminergic treatment. Wearing off will be determined according to the history supplied by the patient that their symptom control fluctuates according to the timing of their dopaminergic therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Diagnosis or suspicion of other cause for Parkinsonism. Patients with clinical features indicating a diagnosis of Progressive Supranuclear Palsy, Multiple Systems Atrophy, and Drug induced Parkinsonism, Dystonic tremor or Essential tremor will not be recruited. Subjects without DaTscan appearances consistent with diagnosis of PD will not be eligible.
- •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).
- •Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/DaTSCAN acquisition.
- •Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale. Although Exenatide may have positive effects on cognition, for the purposes of this trial, patients with dementia will be excluded.
- •Concurrent severe depression defined by a score >16 on the MADRS.
- •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.
- •Already actively participating in a trial of a device, drug or surgical treatment for Parkinson’s disease.
- •Previous exposure to Exenatide.
- •Severely impaired renal function with creatinine clearance <30ml/min.
- •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.
- •History of pancreatitis. Baseline serum amylase value must fall within laboratory normal range +/- 20%.
- •Severe gastrointestinal disease (e.g. gastroparesis).
- •History or suspicion of thyroid cancer. Undiagnosed neck lump, hoarse voice or difficulty swallowing (not attributable to PD diagnosis).
- •Known or suspected intolerance of DaTSCAN or Potassium Iodide administration.
- •Females that are pregnant or breast feeding. There are no safety data regarding Exenatide use in pregnancy. Female participants who are able to become pregnant (defined as women of child bearing potential; see section 4, Glossary) 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 (see section 4, Glossary). WOCBP 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.
- •Potential participants who lack the capacity to give informed consent
- •Any medical, psychiatric or other condition which in the investigator’s opinion compromises the potential participant's ability to participate fully
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