Parkinson's Disease
Conditions
Brief summary
To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease.
Interventions
DRUGApomorphine Nasal Powder
Sponsors
Britannia Pharmaceuticals Ltd.
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
3-week, double-blind, placebo-controlled, 3 × crossover efficacy phase followed by 12 week open label phase, followed by 36 week open continuation phase
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 1 year history of Parkinson's Disease; stable PD medications for 4 weeks; at least one documented off period per day
Exclusion criteria
* hypersensitivity to apomorphine; participation in a clinical trial in the last 12 weeks; pregnant or lactating females
Outcome results
None listed