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

Vectura Limited0 sites66 target enrollmentJanuary 7, 2009

Conditionsnpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11Level: LLTClassification code 10067209Term: <Manually entered code. Term in E.1.1>

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: npredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease
Sponsor: Vectura Limited
Enrollment: 66
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 7, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Vectura Limited

Eligibility Criteria

Inclusion Criteria

•1 Male and female patients between 30 and 90 years of age with a clinical diagnosis of 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 and 2 of the UK Brain Bank Criteria.
•5 Classifies as Hoehn and Yahr Stage II\-IV in an on” state.
•6 Experiences motor fluctuations with recognisable off” periods in control of motor symptoms, as assessed by the Motor Fluctuation Questionnaire. Patients should reliably recognise their off symptoms and should report at least 1 Yes” response to the questions.
•7 Suffers motor fluctuations associated with fluctuating idiopathic PD, and a minimum of a 2\-hour average daily off” time
•8 Has received optimised oral therapy (as documented by the modified FLASQ\-PD), including Levodopa not greater than 1500 mg/day (in combination with decarboxylase inhibitors) for at least the 30 days before Screening. For patients receiving controlled\-release (CR) formulations, the dose limit is based on a 70% bioavailability adjustment (ie, 2143 mg CR \= 1500 mg non\-CR).
•9 Has received for at least the 30 days prior to Screening, or has received in the past but discontinued due to AEs, at least 1 of the following types of medications: DA (eg, cabergoline), COMT inhibitor (eg, entacapone), or monoamine oxidase B inhibitor (eg, selegiline).
•10 Shows dopaminergic responsiveness as defined by \=30% change (reduction) in UPDRS III score compared to the pre\-dose value.

Exclusion Criteria

•1 Participation in a trial with an investigational medicinal product within 3 months prior to Screening.
•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 DA 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 DA therapy.
•5 Women during the lactation period or pregnancy.
•6 Known human immunodeficiency virus or active chronic hepatitis B or C infection.
•7 Patients with the following abnormal Screening laboratory values: Haemoglobin \< 100 g/L; Absolute neutrophil count \< 1\.2 x109/L or \> 10\.0 x109/L; Platelets \< 100 x109/L or \> 600 x109/L; Sodium \< 130 mmol/L or \> 150 mmol/L; Potassium \< 3\.1 mmol/L or \> 5\.6 mmol/L; ALT and/or AST \> 3 x upper limit of normal
•8 Any other 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.
•9 In the investigator’s opinion, the patient is unsuitable for the study for any reason.
•10 ECG abnormalities that, in the opinion of the investigator, would preclude study entry, including significant QTc prolongation at Screening and/or baseline, i.e. QTc \> 450 ms for males or QTc \> 470 ms for females, or any clinically significant atrial or ventricular arrhythmias that may impact the safety of the subject or the conduct of the study as judged by the investigator.