EUCTR2006-005509-79-GB进行中（未招募）1 期
A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease
Vectura Group plc0 个研究点目标入组 42 人开始时间: 2006年12月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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
- •In order to be eligible to enter the study, patients must meet all of the following criteria:
- •1.Male and female patients between 30 and 90 years of age with a clinical diagnosis of idiopathic PD for at least 5 years duration
- •2.Provides voluntary written informed consent
- •3.Is willing and able to comply with study procedures
- •4.Fulfils steps 1 & 2 of the UK Brain Bank Criteria (Appendix 3)
- •5.Classifies as Hoehn & Yahr Stage II-IV in on” state (Appendix 4)
- •6.Experiences motor fluctuations with recognisable off” periods in control of motor symptoms, as assessed by the Motor Fluctuation Questionnaire. Patients should report at least 1 Yes” response to the questions in the Motor Fluctuation Questionnaire (Appendix 5)
- •7.Has received optimised oral therapy including LD 300-1500 mg per day (in combination with decarboxylase inhibitors) for at least the 30 days before Screening. For patients receiving controlled-release (CR) formulations, the dose range is based on a 70% bioavailability adjustment (ie, 100 mg CR = 70 mg non-CR)
- •8.Shows dopaminergic responsiveness as defined by =30% improvement (reduction) in UPDRS III score compared to pre-dose value
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •1.Participation in a trial with an investigational product within 3 months prior to Visit 1
- •2.Serious uncontrolled disease, including serious psychological disorders likely to interfere with the study and/or likely to cause death within 6 months of the study completion
- •3.Previous intolerance to apomorphine
- •4.Previous significant complication from oral dopamine agonist therapy including hospitalisation following dopamine agonist introduction and/or the development of hallucinations or other adverse neuropsychiatric features. Specific severe mental side effects include compulsive behaviour, psychosis, or hallucination that led to withdrawal of oral dopamine agonist therapy.
- •5.Women during the lactation period, pregnancy or of childbearing potential not using a reliable contraceptive method (eg, barrier, intrauterine device, abstinence)
- •6.Known human immunodeficiency virus or active chronic hepatitis B or C infection
- •7.Any clinically significant abnormality following review of screening laboratory data, previous medical history/intercurrent illness, and full physical examination, which may compromise the safety of the patient in the study
- •8.In the investigator’s opinion, the patient is unsuitable for the study for any reason.
- •9.ECG abnormalities that, in the opinion of the investigator, would preclude study entry.
- •10.FEV1 = 65% predicted
- •11.A postural decrease in systolic blood pressure of =20 mmHg, or showing significant clinical symptoms associated with orthostatic hypotension
- •12.Persistent arterial hypotension, with average systolic readings of =110 mmHg
- •13.Persistent elevation of blood pressure, with average systolic readings of =160 mmHg or average diastolic readings of =100 mmHg
- •14.Taking prohibited concomitant medications (Section 7.2)
- •15.Consumption of anabolic steroids or antipsychotics. Administration of the following low dose atypical antipsychotics is permitted:
- •Quetiapine (up to and including 50 mg per day)
- •Risperidone (up to and including 1 mg per day)
- •Olanzipine (up to and including 2.5 mg per day)
- •16.Consumption of the 5HT3 antagonist class including ondansetron, granisetron, dolasetron, palonosetron, and alosetron
- •17.Existing cancer and those in remission for less than 5 years
- •18.Evidence as ascertained from examination, tests or history to indicate cardiovascular, gastrointestinal tract, liver, kidneys, central nervous system, pulmonary system or bone marrow disorders that, in the investigator’s opinion, compromises patient safety
- •19.Known non-responders to apomorphine treatment for off” episodes, eg, in previous challenge tests or trials
- •20.History of drug or alcohol abuse in the 12 months prior to entry
- •21.A history of clinically significant allergies to VR040 formulation constituents (including lactose and opioids) or domperidone
- •22.Signs or symptoms suggestive of psychosis, dementia, Parkinson-plus” syndromes, or unstable systemic disease
- •23.History of stroke, seizure, or other neurological conditions
- •24.Patients with dyskinesia rated 4 in Item 32 of UPDRS IV assessment at Screening (dyskinesia present =76% of a waking day)
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