Trials / Completed
CompletedNCT02352363
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 408 (actual)
- Sponsor
- Acorda Therapeutics · Industry
- Sex
- All
- Age
- 30 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
A randomized, double-blind, placebo-controlled, Phase 2b study in patients with PD (CVT-301-003) demonstrated clinically important, and statistically significant CVT-301-associated improvements in motor function at doses of 35 and 50 mg LD FPD, compared with placebo, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) motor assessment (Part 3); furthermore, CVT-301 was generally safe and well tolerated. A Phase 3, randomized, placebo-controlled study designed to assess the efficacy and safety of 35 mg and 50 mg FPD as an adjunct to a CD/LD regimen in the treatment of OFF symptoms over 12 weeks (CVT-301-004) was conducted in parallel with this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CVT-301 | |
| OTHER | Observational cohort |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2017-05-01
- Completion
- 2017-05-01
- First posted
- 2015-02-02
- Last updated
- 2019-05-28
- Results posted
- 2018-07-10
Locations
76 sites across 14 countries: United States, Austria, Belgium, Czechia, France, Germany, Hungary, Israel, Netherlands, Poland, Romania, Serbia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02352363. Inclusion in this directory is not an endorsement.