Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
NCT ID: NCT01777555
Last Updated: 2018-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
89 participants
INTERVENTIONAL
2013-04-30
2014-01-31
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.
Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
NCT01617135
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
NCT02240030
Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
NCT02242487
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
NCT02352363
A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)
NCT02807675
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.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CVT-301
CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment.
CVT-301
Inhaled Placebo
Subjects randomized to receive placebo in a 1:1 randomization scheme
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CVT-301
Placebo
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 4 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.
Exclusion Criteria
* Previous surgery for PD or plan to have stereotactic surgery during the study period;
* History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
* Adequate lung function as measured by spirometry;
* Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.
30 Years
80 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.
Martin Freed, MD
Role: STUDY_CHAIR
Acorda Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Civitas Investigational Site 1013
Little Rock, Arkansas, United States
Civitas Investigational Site 1004
Boca Raton, Florida, United States
Civitas Investigational Site 1002
Port Charlotte, Florida, United States
Civitas Investigational Site 1015
Tampa, Florida, United States
Civitas Investigational Site 1007
Kansas City, Kansas, United States
Civitas Investigational Site 1010
Boston, Massachusetts, United States
Civitas Investigational Site 1001
Bingham Farms, Michigan, United States
Civitas Investigational Site 1008
Roseville, Michigan, United States
Civitas Investigational Site 1009
Saint Louis, Michigan, United States
Civitas Investigational Site 1005
West Bloomfield, Michigan, United States
Civitas Investigational Site 1011
Kingston, New York, United States
Civitas Investigational Site 1014
Cleveland, Ohio, United States
Civitas Investigational Site 1003
Kirkland, Washington, United States
Civitas Investigational Site 4003
Cassino, , Italy
Civitas Investigational Site 4002
Chieti, , Italy
Civitas Investigational Site 4001
Rome, , Italy
Civitas Investigational Site 3001
Belgrade, , Serbia
Civitas Investigational Site 3002
Belgrade, , Serbia
Civitas Investigational Site 2004
Cambridge, , United Kingdom
Civitas Investigational Site 200
Glasgow, , United Kingdom
Civitas Investigational Site 2001
London, , United Kingdom
Civitas Investigational Site 2003
Stoke-on-Trent, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-005822-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CVT-301-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.