Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Public ClinicalTrials.gov record NCT02242487. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02242487
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 325 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 86 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2015
- Primary completion
- Apr 30, 2018
- Completion
- Apr 30, 2018
- Last update posted
- Aug 13, 2019
2015 – 2018
United States locations
- U.S. sites
- 55
- U.S. states
- 24
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Acorda Site #5020 | Scottsdale | Arizona | 85259 | — |
| Acorda Site #5042 | Fresno | California | 93710 | — |
| Acorda Site #5064 | Fullerton | California | 92835 | — |
| Acorda Site #5035 | Loma Linda | California | 92354 | — |
| Acorda Site #5027 | Long Beach | California | 90806 | — |
| Acorda Site #5037 | Los Angeles | California | 90033 | — |
| Acorda Site #5070 | Pasadena | California | 91105 | — |
| Acorda Site #5047 | Reseda | California | 91335 | — |
| Acorda Site #5068 | Santa Ana | California | 92705 | — |
| Acorda Site #5069 | Torrance | California | 90505 | — |
| Acorda Site #5052 | Washington D.C. | District of Columbia | 20007 | — |
| Acorda Site #5046 | Atlantis | Florida | 33462 | — |
| Acorda Site #5053 | Aventura | Florida | 33180 | — |
| Acorda Site #5013 | Boca Raton | Florida | 33486 | — |
| Acorda Site #5016 | Jacksonville | Florida | 32209 | — |
| Acorda Site #5071 | Maitland | Florida | 32751 | — |
| Acorda Site #5044 | Orlando | Florida | 32806 | — |
| Acorda Site #5060 | Palm Beach Gardens | Florida | 33410 | — |
| Acorda Site #5001 | Port Charlotte | Florida | 33952 | — |
| Acorda Site #5065 | St. Petersburg | Florida | 33713 | — |
| Acorda Site #5012 | Tampa | Florida | 33613 | — |
| Acorda Site #5040 | Atlanta | Georgia | 30329 | — |
| Acorda Site #5025 | Chicago | Illinois | 60611 | — |
| Acorda Site #5030 | Chicago | Illinois | 60612 | — |
| Acorda Site #5011 | Elk Grove Village | Illinois | 60007 | — |
| Acorda Site #5003 | Kansas City | Kansas | 66160 | — |
| Acorda Site #5067 | Baton Rouge | Louisiana | 70810 | — |
| Acorda Site #5057 | Baltimore | Maryland | 21201 | — |
| Acorda Site #5056 | Boston | Massachusetts | 02114 | — |
| Acorda Site #5018 | Boston | Massachusetts | 02118 | — |
| Acorda Site #5002 | Bingham Farms | Michigan | 48025 | — |
| Acorda Site #5014 | West Bloomfield | Michigan | 48322 | — |
| Acorda Site #5041 | Golden Valley | Minnesota | 55427 | — |
| Acorda Site #5006 | St Louis | Missouri | 63110 | — |
| Acorda Site #5023 | Las Vegas | Nevada | 89102 | — |
| Acorda Site #5028 | Albany | New York | 12208 | — |
| Acorda Site #5039 | Brooklyn | New York | 11203 | — |
| Acorda Site #5031 | New York | New York | 10016 | — |
| Acorda Site #5032 | New York | New York | 10029 | — |
| Acorda Site #5004 | New York | New York | 10032 | — |
| Acorda Site #5038 | Syracuse | New York | 13210 | — |
| Acorda Site #5048 | Charlotte | North Carolina | 28204 | — |
| Acorda Site #5005 | Cleveland | Ohio | 44195 | — |
| Acorda Site #5050 | Norwood | Ohio | 45212 | — |
| Acorda Site #5062 | Portland | Oregon | 97239 | — |
| Acorda Site #5036 | Allentown | Pennsylvania | 18103 | — |
| Acorda Site #5010 | Philadelphia | Pennsylvania | 19107 | — |
| Acorda Site #5058 | Willow Grove | Pennsylvania | 19090 | — |
| Acorda Site #5022 | Charleston | South Carolina | 29425 | — |
| Acorda Site #5029 | Nashville | Tennessee | 372322551 | — |
| Acorda Site #5019 | Houston | Texas | 77030 | — |
| Acorda Site #5045 | Houston | Texas | 77030 | — |
| Acorda Site #5049 | Henrico | Virginia | 23226 | — |
| Acorda Site #5059 | Virginia Beach | Virginia | 23456 | — |
| Acorda Site #5051 | Kirkland | Washington | 98034 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02242487, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2019 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02242487 live on ClinicalTrials.gov.