Clinical trial NCT02240030: Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)
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: 2014-09-15
Enrollment: 351
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 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 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:

* Pregnant or lactating females;
* 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.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Part III
timeFrame: 30 minutes post-dose at week 12
Secondary outcomes:
measure: Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
timeFrame: at week 12
measure: UPDRS Part III Motor Score at 20 Minutes
timeFrame: at week 12
measure: Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12
timeFrame: week 12
measure: UPDRS Part III at 10 Min.
timeFrame: week 12
measure: PD Patient Diary
timeFrame: post week 12
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: 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: Zaspa
country: Poland
facility: Acorda Site #5305
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:
citation: 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.