Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease Motor fluctuations levodopa inhaled drugs OFF episodes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 351
Healthy volunteers: no

Brief summary:
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.

Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.

Detailed description:

Arms:
arm 1: Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration arm 2: Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration arm 3: Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.

Interventions: intervention 1: CVT-301 Low Dose intervention 2: CVT-301 High Dose intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: