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NCT01777555 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
A Phase 2 study of Idiopathic Parkinson´s Disease, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
- 20
- Study locations
NCT01777555: Completed Phase 2 study of Idiopathic Parkinson´s Disease, sponsored by Acorda Therapeutics.
NCT01777555 is a Phase 2 study of Idiopathic Parkinson´s Disease that has completed, run by Acorda Therapeutics. The registered enrollment target is 89 participants, below the 207-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01777555, a Phase 2 study of Idiopathic Parkinson´s Disease, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 89 participants
- Enrollment target
- 20
- Study locations
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 |
What the finished NCT01777555 record still lists
NCT01777555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 207-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (57% lower).
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.
NCT01777555 names 20 study sites across 9 states, led by Other, Michigan, Florida.
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.
What interventions are being tested in trial NCT01777555?
The interventions under investigation include: Placebo (DRUG), CVT-301 (DRUG).
Who is sponsoring clinical trial NCT01777555?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
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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