Trials / Completed
CompletedNCT02240030
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 351 (actual)
- Sponsor
- Acorda Therapeutics · Industry
- Sex
- All
- Age
- 30 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CVT-301 Low Dose | |
| DRUG | CVT-301 High Dose | |
| OTHER | Placebo |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2014-09-15
- Last updated
- 2019-05-28
- Results posted
- 2018-04-17
Locations
74 sites across 5 countries: United States, Canada, Czechia, Poland, Spain
Source: ClinicalTrials.gov record NCT02240030. Inclusion in this directory is not an endorsement.