ISRCTN41929673
Completed
Phase 2
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 sites66 target enrollmentFebruary 16, 2009
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Parkinson's disease
- Sponsor
- Vectura Limited (UK)
- Enrollment
- 66
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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