A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With ?On-Off? or ?Wearing-Off? Effects Associated With Parkinson?s Disease - ND

Conditions: MedDRA version: 9.1Level: HLGTClassification code 10028037
MedDRA version: 9.1Level: PTClassification code 10030312
Parkinson?s desease

Registration Number: EUCTR2008-004447-11-IT

Lead Sponsor: VECTURA LIMITED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 66

Inclusion Criteria

Male and female patients are eligible for participation in this study if they are between the ages of 30 and 90 years with a clinical diagnosis of PD of at least 5 years duration; fulfilled Steps 1 and 2 of the United Kingdom (UK) Brain Bank Criteria; classified as Hoehn and Yahr Stage II-IV in ?on? state; have suffered from motor fluctuations associated with fluctuating idiopathic PD and a minimum of a 2-hour average daily ?off? time; and showed dopaminergic responsiveness as defined by ≥30% change (reduction) in UPDRS III score compared to the pre-dose value. Patients must be optimised on oral therapy (as documented by a modified Florida Surgical Questionnaire for PD [FLASQ-PD]), including levodopa (LD) not greater than 1500 mg/day (in combination with decarboxylase inhibitors) at least 30 days before Screening; also, patients should be receiving (for at least 30 days), or have received in the past, but discontinued due to AEs, at least 1 of the following types of medications: dopamine agonist (DA), catechol-O-methyltransferase inhibitor (COMT), or monoamine oxidase B inhibitor (MAOB). Patients must understand (with carer assistance) their daily medications.
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

Exclusion Criteria

Patients ineligible for participation include those with very serious or advanced disease. Additionally, patients with dyskinesias rated as severe, ie, ≥2 in Item 32 of the UPDRS IV assessment and ≥2 in Item 33 of the UPDRS IV assessment, at Screening are ineligible for the study. Patients are excluded who have had previous intolerance or allergy to apomorphine or any of its constituents, or any previous significant historic complication from oral DA therapy. Pregnant or lactating females, and patients with known human immunodeficiency virus or active chronic hepatitis B or C infection are excluded. Also, patients are excluded who have any clinically significant abnormality or finding from examination, tests, or history that may compromise patient safety, specifically any history of renal or hepatic impairment. Patients are excluded who have relevant ECG abnormalities; FEV1 ≤65% predicted; evidence of orthostatic or persistent arterial hypotension; hypertension; cancer; those taking certain prohibited medications or anabolic steroids or antipsychotics (some exceptions apply); those taking 5HT3 antagonists or clozapine; and those with history of drug or alcohol abuse. Patients are also excluded if they are known non-responders to apomorphine treatment for ?off? episodes, eg, in previous challenge tests or trials.