NCT02242487

Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 30 Years – 86 Years
• Healthy volunteers: Not accepted

Summary

This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study for those patients who participated in that study and remain eligible for this study. In addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009 (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	CVT-301

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2014-09-17
• Last updated: 2019-08-14
• Results posted: 2019-07-30

Locations

74 sites across 5 countries: United States, Canada, Czechia, Poland, Spain