drugset / Trial / NCT02352363

Randomized Safety Study of CVT-301 Compared to an Observational Control Group

NCT02352363

Phase 3 Completed 408 enrolled Acorda Therapeutics
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-03
Primary completion
2017-05
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Levodopa Small molecule Inhaled

Indications