Parkinson's Disease Clinical Trial
Official title:
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
'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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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