Randomized Safety Study of CVT-301 Compared to an Observational Control Group
Public ClinicalTrials.gov record NCT02352363. 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 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02352363
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 408 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 85 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, 2017
- Completion
- Apr 30, 2017
- Last update posted
- May 27, 2019
2015 – 2017
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Acorda Site #7145 | Scottsdale | Arizona | 85258 | — |
| Acorda Site # 7142 | Fountain Valley | California | 92708 | — |
| Acorda Site #7139 | Panorama City | California | 91402 | — |
| Acorda Site #7141 | Sunnyvale | California | 94085 | — |
| Acorda Site #7137 | Ormond Beach | Florida | 32174 | — |
| Acorda Site #7135 | St. Petersburg | Florida | 33713 | — |
| Acorda Site #7130 | Sunrise | Florida | 33351 | — |
| Acorda Site #7133 | Atlanta | Georgia | 30342 | — |
| Acorda Site #7134 | Atlanta | Georgia | 30342 | — |
| Acorda Site #7131 | Decatur | Georgia | 30033 | — |
| Acorda Site #7138 | Honolulu | Hawaii | 96734 | — |
| Acorda Site #7140 | Des Moines | Iowa | 50309 | — |
| Acorda Site #7150 | Baton Rouge | Louisiana | 70810 | — |
| Acorda Site #7148 | Toledo | Ohio | 43614 | — |
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 62 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02352363, 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 May 27, 2019 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02352363 live on ClinicalTrials.gov.