NCT01693081

Phase IIa Multicentre Study Investigating of VR040 in Parkinson's Disease

A Clinic-Based, Phase IIa, Double-Blind, Placebo- Controlled, Ascending-Dose, Multicentre Study of Safety, Tolerability, Efficacy and Pharmacokinetics of VR040 in Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: South Glasgow University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

'Off periods' where people with Parkinson's disease are slow, stiff and unable to function are disabling, and a treatment which can converts people to a "on", good, able to function state would be extremely useful. We assessed safety, tolerability and efficacy of inhaled dry powder apomorphine (VR040) in a clinic-based study in this setting.

Detailed description

Background: 'Off' periods increase as Parkinson's disease progresses and the benefits of standard therapy wane. Subcutaneous apomorphine rescues 'off' periods, but patient self-injection and adverse cutaneous effects are sometimes problematic. Methods: We assessed safety, tolerability and efficacy of inhaled dry powder apomorphine (VR040) in a clinic-based Phase II study. Of 48 patients recruited at 9 sites, 47 were randomized 2:1 inhaled apomorphine:placebo. Respirable doses (drug predicted to reach the lung) ascending through 1.5mg, 2.3mg, 3.0mg, and 4.0mg until efficacy was achieved, were administered to patients in a practically defined 'off' state. The primary endpoint was the response in unified Parkinson's disease rating scale Part 3 (UPDRS 3), at the highest dose received by the patient. Secondary endpoints included time to 'on', the proportion of patients converting from 'off' to 'on', and pharmacokinetics.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	VR040/Aspirair® inhaler	Dry Powder inhaled apomorphine
DRUG	placebo

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-07-01
• Completion: 2009-07-01
• First posted: 2012-09-26
• Last updated: 2012-09-26

Locations

9 sites across 2 countries: Serbia, United Kingdom