Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
NCT ID: NCT02240030
Last Updated: 2019-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
351 participants
INTERVENTIONAL
2014-11-30
2016-12-31
Brief Summary
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Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CVT-301 Low Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
CVT-301 Low Dose
CVT-301 High Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
CVT-301 High Dose
Placebo
Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
Placebo
Interventions
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CVT-301 Low Dose
CVT-301 High Dose
Placebo
Other Intervention Names
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Eligibility Criteria
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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 LD dose \<1600 mg/day;
* Able to perform a spirometry maneuver in the ON and OFF states;
* Normal cognition confirmed by MMSE score ≥25
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;
* 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 contraindication to performing routine spirometry.
30 Years
85 Years
ALL
No
Sponsors
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Acorda Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Charles Oh, MD
Role: STUDY_DIRECTOR
Acorda Therapeutics
Locations
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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 #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 #5305
Zaspa, , 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
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References
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LeWitt PA, Hauser RA, Pahwa R, Isaacson SH, Fernandez HH, Lew M, Saint-Hilaire M, Pourcher E, Lopez-Manzanares L, Waters C, Rudzinska M, Sedkov A, Batycky R, Oh C; SPAN-PD Study Investigators. Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2019 Feb;18(2):145-154. doi: 10.1016/S1474-4422(18)30405-8.
Related Links
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Click here for more information about this study: CVT-301-004
Other Identifiers
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CVT-301-004
Identifier Type: -
Identifier Source: org_study_id
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