Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
NCT ID: NCT02242487
Last Updated: 2019-08-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
325 participants
INTERVENTIONAL
2015-03-31
2018-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
NCT02240030
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
NCT02352363
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
NCT01777555
Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
NCT01617135
Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)
NCT03887884
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CVT-301 Low Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
CVT-301
CVT-301 High Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
CVT-301
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CVT-301
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Hoehn and Yahr Stage 1-3 in an "on" state;
* Require levodopa-containing medication regimen at least 3 times during the waking day;
* Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
* Are on stable PD medication regimen;
* Total daily levodopa (LD) dose \<1600 mg/day;
* Able to perform a spirometry maneuver in the ON and OFF states
* Normal cognition confirmed by Mini Mental State Examination (MMSE) score ≥25 ;
Exclusion Criteria
* Previous surgery for PD or plan to have stereotactic surgery during the study period. Patients who have had deep brain stimulation \[DBS\] will also be excluded unless the procedure was performed more than 6 months prior to study enrollment.
* History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
* Known contraindication to the use of levodopa;
* Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
* Any any contraindication to performing routine spirometry.
30 Years
86 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Acorda Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charles Oh, MD
Role: STUDY_DIRECTOR
Acorda Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Acorda Site #5020
Scottsdale, Arizona, United States
Acorda Site #5042
Fresno, California, United States
Acorda Site #5064
Fullerton, California, United States
Acorda Site #5035
Loma Linda, California, United States
Acorda Site #5027
Long Beach, California, United States
Acorda Site #5037
Los Angeles, California, United States
Acorda Site #5070
Pasadena, California, United States
Acorda Site #5047
Reseda, California, United States
Acorda Site #5068
Santa Ana, California, United States
Acorda Site #5069
Torrance, California, United States
Acorda Site #5052
Washington D.C., District of Columbia, United States
Acorda Site #5046
Atlantis, Florida, United States
Acorda Site #5053
Aventura, Florida, United States
Acorda Site #5013
Boca Raton, Florida, United States
Acorda Site #5016
Jacksonville, Florida, United States
Acorda Site #5071
Maitland, Florida, United States
Acorda Site #5044
Orlando, Florida, United States
Acorda Site #5060
Palm Beach Gardens, Florida, United States
Acorda Site #5001
Port Charlotte, Florida, United States
Acorda Site #5065
St. Petersburg, Florida, United States
Acorda Site #5012
Tampa, Florida, United States
Acorda Site #5040
Atlanta, Georgia, United States
Acorda Site #5025
Chicago, Illinois, United States
Acorda Site #5030
Chicago, Illinois, United States
Acorda Site #5011
Elk Grove Village, Illinois, United States
Acorda Site #5003
Kansas City, Kansas, United States
Acorda Site #5067
Baton Rouge, Louisiana, United States
Acorda Site #5057
Baltimore, Maryland, United States
Acorda Site #5056
Boston, Massachusetts, United States
Acorda Site #5018
Boston, Massachusetts, United States
Acorda Site #5002
Bingham Farms, Michigan, United States
Acorda Site #5014
West Bloomfield, Michigan, United States
Acorda Site #5041
Golden Valley, Minnesota, United States
Acorda Site #5006
St Louis, Missouri, United States
Acorda Site #5023
Las Vegas, Nevada, United States
Acorda Site #5028
Albany, New York, United States
Acorda Site #5039
Brooklyn, New York, United States
Acorda Site #5031
New York, New York, United States
Acorda Site #5032
New York, New York, United States
Acorda Site #5004
New York, New York, United States
Acorda Site #5038
Syracuse, New York, United States
Acorda Site #5048
Charlotte, North Carolina, United States
Acorda Site #5005
Cleveland, Ohio, United States
Acorda Site #5050
Norwood, Ohio, United States
Acorda Site #5062
Portland, Oregon, United States
Acorda Site #5036
Allentown, Pennsylvania, United States
Acorda Site #5010
Philadelphia, Pennsylvania, United States
Acorda Site #5058
Willow Grove, Pennsylvania, United States
Acorda Site #5022
Charleston, South Carolina, United States
Acorda Site #5029
Nashville, Tennessee, United States
Acorda Site #5019
Houston, Texas, United States
Acorda Site #5045
Houston, Texas, United States
Acorda Site #5049
Henrico, Virginia, United States
Acorda Site #5059
Virginia Beach, Virginia, United States
Acorda Site #5051
Kirkland, Washington, United States
Acorda Site #5103
London, Ontario, Canada
Acorda Site #5104
Ottawa, Ontario, Canada
Acorda Site #5105
Toronto, Ontario, Canada
Acorda Site #5201
Prague, , Czechia
Acorda Site #5203
Prague, , Czechia
Acorda Site #5305
Gdansk, Zappa, Poland
Acorda Site #5304
Katowice, , Poland
Acorda Site #5306
Krakow, , Poland
Acorda Site #5303
Krakow, , Poland
Acorda Site #5307
Krakow, , Poland
Acorda Site #5302
Lodz, , Poland
Acorda Site #5308
Warsaw, , Poland
Acorda Site #5301
Warsaw, , Poland
Acorda Site #5407
Pamplona, Navarre, Spain
Acorda Site #5404
Barcelona, , Spain
Acorda Site #5406
Barcelona, , Spain
Acorda Site #5405
Madrid, , Spain
Acorda Site #5403
San Sebastián, , Spain
Acorda Site #5401
Sant Cugat del Vallès, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Click here for more information about this study:CVT-301-004E
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CVT-301-004E
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.