VR040/2/008

• Research type

  Research Study

• Full title

  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

• Contact name

  Donald Grosset

• Sponsor organisation

  Vectura Ltd

• Eudract number

  2008-004447-11

• Research summary

  Title: A Phase IIb Efficacy and safety of orally inhaled apomorphine in patients with Parkinson's disease (PD). Investigational Product: Inhaled Apomorphine. Number of Sites/Countries: 15 centres in 3 EU countries. Indication: Patients witflutuating idiopathic Parkinson's disease who have moto flutuations with recognisable motor 'on-off' and 'wearing-off'periods. Design: Clinic- and home-based, randomised, double-blind, placebo-controlled, parallel-group, dose titration, multicentre study. The study objectives are to identify optimal doses of Inhaled Apomorphine for future evaluation, to determine its efficacy in controlling the 'on-off' and 'wearing-off' effects associated with flutuating idiopathic PD and to determine its safety and tolerability. Also to determine patients' acceptance of and ability to use an active inhaler and to verify its suitability for home use. Study Duration: Approximately 10 months from start of Screening to last patient, last visit. Sample Size: At least 66 patients enrolled to provide 57 evaluable (38 in the active treatment group, 19 in the placebo group). Principal Selection Criteria: Male and female patients aged 30 to 90 years with a diagnosis of PD of at least 5 years duration; fulfilled Steps 1 and 2 of the UK Brain Bank Criteria; classified as Hoehn & Yahr Stage II-IV in 'on' state; have suffered from motoflutuations associated witflutuating idiopathic PD and a minimum of a 2-hour average daily 'off' time; and showed dopaminergic responsiveness as defined by: 30% improvement (reduction) in UPDRS III score. Patients must be optimised on oral therapy. Investigational Product Formulation: Apomorphine Hydrochloride for inhalation. Investigational Product Dosage: Four ascending doses

• REC name

  Scotland A REC

• REC reference

  08/MRE00/80

• Date of REC Opinion

  12 Nov 2008

• REC opinion

  Further Information Favourable Opinion