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NCT02240030 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
A Phase 3 study of Idiopathic Parkinson´s Disease, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 351
- Enrollment target
- 20
- Study locations
NCT02240030: Completed Phase 3 study of Idiopathic Parkinson´s Disease, sponsored by Acorda Therapeutics.
NCT02240030 is a Phase 3 study of Idiopathic Parkinson´s Disease that has completed, run by Acorda Therapeutics. The registered enrollment target is 351 participants, above the 170-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (106% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02240030, a Phase 3 study of Idiopathic Parkinson´s Disease, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 351 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. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.
Primary Outcome
Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG CVT-301 Low Dose
- DRUG CVT-301 High Dose
Study Locations (20)
California
- Acorda Site #5042 - Fresno
- Acorda Site #5064 - Fullerton
- Acorda Site #5035 - Loma Linda
- Acorda Site #5027 - Long Beach
- Acorda Site #5037 - Los Angeles
- Acorda Site #5070 - Pasadena
- Acorda Site #5047 - Reseda
- Acorda Site #5068 - Santa Ana
- Acorda Site #5069 - Torrance
Florida
- Acorda Site #5046 - Atlantis
- Acorda Site #5053 - Aventura
- Acorda Site #5013 - Boca Raton
- Acorda Site #5016 - Jacksonville
- Acorda Site #5071 - Maitland
- Acorda Site #5044 - Orlando
- Acorda Site #5060 - Palm Beach Gardens
- Acorda Site #5001 - Port Charlotte
- Acorda Site #5065 - St. Petersburg
Arizona
- Acorda Site #5020 - Scottsdale
District of Columbia
- Acorda Site #5052 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
What the finished NCT02240030 record still lists
NCT02240030 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, above the 170-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (106% higher).
The record links to 1 condition, with Idiopathic Parkinson´s Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02240030 names 20 study sites across 4 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02240030 about?
NCT02240030 is a clinical study titled "Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With 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. Patients who successfully c...
What is the current status of trial NCT02240030?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 351 participants. The study started on 2014-11. Estimated completion is 2016-12.
What conditions does trial NCT02240030 study?
This clinical trial studies the following conditions: Idiopathic Parkinson´s Disease.
What interventions are being tested in trial NCT02240030?
The interventions under investigation include: Placebo (OTHER), CVT-301 Low Dose (DRUG), CVT-301 High Dose (DRUG).
Who is sponsoring clinical trial NCT02240030?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02240030 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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