Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
NCT01777555 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CVT-301
Study Locations (20)
Other
- Civitas Investigational Site 4003 — Cassino
- Civitas Investigational Site 4002 — Chieti
- Civitas Investigational Site 4001 — Rome
- Civitas Investigational Site 3001 — Belgrade
- Civitas Investigational Site 3002 — Belgrade
- Civitas Investigational Site 2004 — Cambridge
- Civitas Investigational Site 200 — Glasgow
Michigan
- Civitas Investigational Site 1001 — Bingham Farms
- Civitas Investigational Site 1008 — Roseville
- Civitas Investigational Site 1009 — Saint Louis
- Civitas Investigational Site 1005 — West Bloomfield
Florida
- Civitas Investigational Site 1004 — Boca Raton
- Civitas Investigational Site 1002 — Port Charlotte
- Civitas Investigational Site 1015 — Tampa
Arkansas
- Civitas Investigational Site 1013 — Little Rock
Kansas
- Civitas Investigational Site 1007 — Kansas City
Massachusetts
- Civitas Investigational Site 1010 — Boston
New York
- Civitas Investigational Site 1011 — Kingston
Ohio
- Civitas Investigational Site 1014 — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01777555
The ClinicalTrials.gov registry entry for NCT01777555 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acorda Therapeutics, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Idiopathic Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01777555 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Michigan, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01777555 about?
NCT01777555 is a clinical study titled "Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes". 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.
What is the current status of trial NCT01777555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2013-04. Estimated completion is 2014-01.
What conditions does trial NCT01777555 study?
This clinical trial studies the following conditions: Idiopathic Parkinson's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01777555?
The interventions under investigation include: Placebo (DRUG), CVT-301 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01777555?
This trial is sponsored by Acorda Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01777555 being conducted?
This trial has 20 study locations across Arkansas, Florida, Kansas, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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