Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes

Acorda Therapeutics

Status and phase

Completed

Phase 2

Conditions

Idiopathic Parkinson's Disease

Treatments

Drug: Placebo

Drug: CVT-301

Study type

Interventional

Funder types

Industry

Identifiers

NCT01777555

CVT-301-003

2012-005822-31 (EudraCT Number)

Details and patient eligibility

About

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

Enrollment

89 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
Hoehn and Yahr Stage 1-3 in an "on" state;
Require levodopa-containing medication regimen at least 4 times during the waking day;
Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
Are on stable PD medication regimen.

Exclusion criteria

Pregnant or lactating females;
Previous surgery for PD or plan to have stereotactic surgery during the study period;
History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
Adequate lung function as measured by spirometry;
Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.