A phase IIb randomised, double-blind, placebo-controlled, parallel-group study investigating the efficacy and safety of inhaled apomorphine in patients with on-off or wearing-off effects associated with Parkinson's disease

Vectura Limited (UK)0 个研究点目标入组 66 人开始时间: 2009年2月16日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Male and female patients between the ages of 30 and 90 years
•2. A clinical diagnosis of PD of at least 5 years duration
•3. Fulfilled Steps 1 and 2 of the UK Brain Bank Criteria
•4. Classified as Hoehn and Yahr Stage II - IV in on state
•5. Have suffered from motor fluctuations associated with fluctuating idiopathic PD and a minimum of a 2-hour average daily off time
•6. Showed dopaminergic responsiveness as defined by equal to or more than 30% change (reduction) in Unified Parkinson's Disease Rating Scale (UPDRS III) score compared to the pre-dose value
•7. Optimised on oral therapy, including levodopa not greater than 1500 mg/day (in combination with decarboxylase inhibitors) at least 30 days before screening
•8. Receiving (for at least 30 days), or have received in the past, but discontinued due to adverse events (AEs), at least one of the following types of medications:
•8.1. Dopamine agonist
•8.2. Catechol-o-methyltransferase inhibitor
•8.3. Monoamine oxidase B inhibitor
•9. Understand (with carer assistance) their daily medications

•1. Very serious or advanced disease
•2. Dyskinesias rated as severe, i.e. equal to 2 in Item 32 of the UPDRS IV assessment and equal to 2 in Item 33 of the UPDRS IV assessment, at screening
•3. Previous intolerance or allergy to apomorphine or any of its constituents, or any previous significant historic complication from oral dopamine agonist (DA) therapy
•4. Pregnant or lactating females, and patients with known human immunodeficiency virus or active chronic hepatitis B or C infection
•5. Any clinically significant abnormality or finding from examination, tests, or history that may compromise patient safety, specifically any history of renal or hepatic impairment
•6. Relevant electrocardiogram (ECG) abnormalities
•7. Forced expiratory volume in one second (FEV1) equals 65% predicted
•8. Evidence of orthostatic or persistent arterial hypotension
•9. Hypertension
•10. Cancer
•11. Those taking certain prohibited medications or anabolic steroids or antipsychotics (some exceptions apply)
•12. Those taking 5HT3 antagonists or clozapine
•13. History of drug or alcohol abuse
•14. Current, or a history of, hypersensitivity to domperidone, pituitary tumour (prolactinoma), or gastrointestinal blockage or haemorrhage
•15. Known non-responders to apomorphine treatment for off episodes, e.g. in previous challenge tests or trials

发起方

Vectura Limited (UK)