At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 408 enrolled
Drug / intervention
CVT-301 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating CVT-301 and Observational cohort for Idiopathic Parkinson's Disease. Completed, enrolled 408 participants across 76 sites in 14 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Parkinson's Disease
CountriesAustria, Belgium, Czechia, France, Germany, Hungary, Israel, Netherlands, Poland, Romania, Serbia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartMar 2015
Primary CompletionMay 2017
TodayJul 2026
First PostedFeb 2, 2015
Enrollment StartMar 1, 2015
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.4 years ago
Interventions
CVT-301drug
Observational cohortother