Phase 3CompletedAge-related condition
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control
- Sponsor
- Acorda Therapeutics (Industry)
- Enrollment
- 408 enrolled
- Conditions
- Idiopathic Parkinson's Disease
- Interventions
- CVT-301; Observational cohort
- Ages
- adults, older adults
- Registry
- NCT02352363
Full record on ClinicalTrials.gov
From the registry
This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.
Primary outcomes
- Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]
- Pulmonary Safety Assessed by Forced Vital Capacity [FVC].
- Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.
History
Last registry update
Results first posted
Primary completion
Started
Registered