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NCT02242487 · ClinicalTrials.gov registry record · Phase 3
Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
A Phase 3 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 325
- Enrollment target
NCT02242487 is a Phase 3 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 325 participants.
The verdict
NCT02242487, a Phase 3 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 325 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG CVT-301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02242487
The ClinicalTrials.gov registry entry for NCT02242487 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acorda Therapeutics, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CVT-301 is the first listed.
NCT02242487 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02242487 about?
NCT02242487 is a clinical study titled "Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes". 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....
What is the current status of trial NCT02242487?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 325 participants. The study started on 2015-03. Estimated completion is 2018-05.
What interventions are being tested in trial NCT02242487?
The interventions under investigation include: CVT-301 (DRUG).
Who is sponsoring clinical trial NCT02242487?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
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