Clinical trial NCT02242487: Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Official title: A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease
Motor fluctuations
levodopa
inhaled drugs
OFF episodes
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 325
Sex: ALL
Minimum age (years): 30
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study for those patients who participated in that study and remain eligible for this study. In addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009 (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.


Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
* 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:

* Pregnant or lactating females;
* 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.

Primary outcomes:
measure: Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
timeFrame: Change from baseline at 52 weeks
measure: Pulmonary Safety for CVT-301 Change From Baseline for FVC.
timeFrame: Change from baseline at 52 weeks
measure: Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).
timeFrame: Change from baseline at 52 weeks
Secondary outcomes:
measure: Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
timeFrame: At Treatment Visit - TV6 (Week 52)
measure: Change From Baseline in OFF Time.
timeFrame: Change from baseline through 12 months duration of outpatient use
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Acorda Site #5020
state: Arizona
city: Fresno
country: United States
facility: Acorda Site #5042
state: California
city: Fullerton
country: United States
facility: Acorda Site #5064
state: California
city: Loma Linda
country: United States
facility: Acorda Site #5035
state: California
city: Long Beach
country: United States
facility: Acorda Site #5027
state: California
city: Los Angeles
country: United States
facility: Acorda Site #5037
state: California
city: Pasadena
country: United States
facility: Acorda Site #5070
state: California
city: Reseda
country: United States
facility: Acorda Site #5047
state: California
city: Santa Ana
country: United States
facility: Acorda Site #5068
state: California
city: Torrance
country: United States
facility: Acorda Site #5069
state: California
city: Washington
country: United States
facility: Acorda Site #5052
state: District of Columbia
city: Atlantis
country: United States
facility: Acorda Site #5046
state: Florida
city: Aventura
country: United States
facility: Acorda Site #5053
state: Florida
city: Boca Raton
country: United States
facility: Acorda Site #5013
state: Florida
city: Jacksonville
country: United States
facility: Acorda Site #5016
state: Florida
city: Maitland
country: United States
facility: Acorda Site #5071
state: Florida
city: Orlando
country: United States
facility: Acorda Site #5044
state: Florida
city: Palm Beach Gardens
country: United States
facility: Acorda Site #5060
state: Florida
city: Port Charlotte
country: United States
facility: Acorda Site #5001
state: Florida
city: Saint Petersburg
country: United States
facility: Acorda Site #5065
state: Florida
city: Tampa
country: United States
facility: Acorda Site #5012
state: Florida
city: Atlanta
country: United States
facility: Acorda Site #5040
state: Georgia
city: Chicago
country: United States
facility: Acorda Site #5025
state: Illinois
city: Chicago
country: United States
facility: Acorda Site #5030
state: Illinois
city: Elk Grove Village
country: United States
facility: Acorda Site #5011
state: Illinois
city: Kansas City
country: United States
facility: Acorda Site #5003
state: Kansas
city: Baton Rouge
country: United States
facility: Acorda Site #5067
state: Louisiana
city: Baltimore
country: United States
facility: Acorda Site #5057
state: Maryland
city: Boston
country: United States
facility: Acorda Site #5056
state: Massachusetts
city: Boston
country: United States
facility: Acorda Site #5018
state: Massachusetts
city: Bingham Farms
country: United States
facility: Acorda Site #5002
state: Michigan
city: West Bloomfield
country: United States
facility: Acorda Site #5014
state: Michigan
city: Golden Valley
country: United States
facility: Acorda Site #5041
state: Minnesota
city: Saint Louis
country: United States
facility: Acorda Site #5006
state: Missouri
city: Las Vegas
country: United States
facility: Acorda Site #5023
state: Nevada
city: Albany
country: United States
facility: Acorda Site #5028
state: New York
city: Brooklyn
country: United States
facility: Acorda Site #5039
state: New York
city: New York
country: United States
facility: Acorda Site #5031
state: New York
city: New York
country: United States
facility: Acorda Site #5032
state: New York
city: New York
country: United States
facility: Acorda Site #5004
state: New York
city: Syracuse
country: United States
facility: Acorda Site #5038
state: New York
city: Charlotte
country: United States
facility: Acorda Site #5048
state: North Carolina
city: Cleveland
country: United States
facility: Acorda Site #5005
state: Ohio
city: Norwood
country: United States
facility: Acorda Site #5050
state: Ohio
city: Portland
country: United States
facility: Acorda Site #5062
state: Oregon
city: Allentown
country: United States
facility: Acorda Site #5036
state: Pennsylvania
city: Philadelphia
country: United States
facility: Acorda Site #5010
state: Pennsylvania
city: Willow Grove
country: United States
facility: Acorda Site #5058
state: Pennsylvania
city: Charleston
country: United States
facility: Acorda Site #5022
state: South Carolina
city: Nashville
country: United States
facility: Acorda Site #5029
state: Tennessee
city: Houston
country: United States
facility: Acorda Site #5019
state: Texas
city: Houston
country: United States
facility: Acorda Site #5045
state: Texas
city: Henrico
country: United States
facility: Acorda Site #5049
state: Virginia
city: Virginia Beach
country: United States
facility: Acorda Site #5059
state: Virginia
city: Kirkland
country: United States
facility: Acorda Site #5051
state: Washington
city: London
country: Canada
facility: Acorda Site #5103
state: Ontario
city: Ottawa
country: Canada
facility: Acorda Site #5104
state: Ontario
city: Toronto
country: Canada
facility: Acorda Site #5105
state: Ontario
city: Prague
country: Czechia
facility: Acorda Site #5201
city: Prague
country: Czechia
facility: Acorda Site #5203
city: Gdańsk
country: Poland
facility: Acorda Site #5305
state: Zappa
city: Katowice
country: Poland
facility: Acorda Site #5304
city: Krakow
country: Poland
facility: Acorda Site #5303
city: Kraków
country: Poland
facility: Acorda Site #5306
city: Kraków
country: Poland
facility: Acorda Site #5307
city: Lodz
country: Poland
facility: Acorda Site #5302
city: Warsaw
country: Poland
facility: Acorda Site #5308
city: Warsaw
country: Poland
facility: Acorda Site #5301
city: Pamplona
country: Spain
facility: Acorda Site #5407
state: Navarre
city: Barcelona
country: Spain
facility: Acorda Site #5404
city: Barcelona
country: Spain
facility: Acorda Site #5406
city: Madrid
country: Spain
facility: Acorda Site #5405
city: San Sebastián
country: Spain
facility: Acorda Site #5403
city: Sant Cugat Del Vallès
country: Spain
facility: Acorda Site #5401
Study officials:
affiliation: Acorda Therapeutics
name: Charles Oh, MD
role: STUDY_DIRECTOR
References: