Back to resultsTwelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Primary Purpose
Idiopathic Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CVT-301
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's Disease, Motor fluctuations, levodopa, inhaled drugs, OFF episodes
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.
Sites / Locations
- Acorda Site #5020
- Acorda Site #5042
- Acorda Site #5064
- Acorda Site #5035
- Acorda Site #5027
- Acorda Site #5037
- Acorda Site #5070
- Acorda Site #5047
- Acorda Site #5068
- Acorda Site #5069
- Acorda Site #5052
- Acorda Site #5046
- Acorda Site #5053
- Acorda Site #5013
- Acorda Site #5016
- Acorda Site #5071
- Acorda Site #5044
- Acorda Site #5060
- Acorda Site #5001
- Acorda Site #5065
- Acorda Site #5012
- Acorda Site #5040
- Acorda Site #5025
- Acorda Site #5030
- Acorda Site #5011
- Acorda Site #5003
- Acorda Site #5067
- Acorda Site #5057
- Acorda Site #5056
- Acorda Site #5018
- Acorda Site #5002
- Acorda Site #5014
- Acorda Site #5041
- Acorda Site #5006
- Acorda Site #5023
- Acorda Site #5028
- Acorda Site #5039
- Acorda Site #5031
- Acorda Site #5032
- Acorda Site #5004
- Acorda Site #5038
- Acorda Site #5048
- Acorda Site #5005
- Acorda Site #5050
- Acorda Site #5062
- Acorda Site #5036
- Acorda Site #5010
- Acorda Site #5058
- Acorda Site #5022
- Acorda Site #5029
- Acorda Site #5019
- Acorda Site #5045
- Acorda Site #5049
- Acorda Site #5059
- Acorda Site #5051
- Acorda Site #5103
- Acorda Site #5104
- Acorda Site #5105
- Acorda Site #5201
- Acorda Site #5203
- Acorda Site #5305
- Acorda Site #5304
- Acorda Site #5303
- Acorda Site #5306
- Acorda Site #5307
- Acorda Site #5302
- Acorda Site #5308
- Acorda Site #5301
- Acorda Site #5407
- Acorda Site #5404
- Acorda Site #5406
- Acorda Site #5405
- Acorda Site #5403
- Acorda Site #5401
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CVT-301 Low Dose
CVT-301 High Dose
Arm Description
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
Outcomes
Primary Outcome Measures
Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1 (forced expiratory volume in 1 second) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.
Pulmonary Safety for CVT-301 Change From Baseline for FVC.
To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FVC, (forced vital capacity) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.
Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).
To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1/FVC (FEV1-forced expiratory volume in 1 second and (FVC) forced vital capacity ratio) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.
Secondary Outcome Measures
Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
Count of patients achieving resolution of an OFF to an ON state within 60 minutes after study drug is administered in the clinic, and maintaining the ON state at 60 minutes after study drug administration (per the examiner's subjective assessment).
Change From Baseline in OFF Time.
Patient reported total daily OFF time and was assessed by the patient and recorded in the patient Diary. An "OFF state" is defined as the time when medication is not providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms. Patients will record their ON and OFF states in their diaries at home.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02242487
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Parkinson's Disease, Motor fluctuations, levodopa, inhaled drugs, OFF episodes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVT-301 Low Dose
Arm Type
Experimental
Arm Description
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
Arm Title
CVT-301 High Dose
Arm Type
Experimental
Arm Description
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
Intervention Type
Drug
Intervention Name(s)
CVT-301
Other Intervention Name(s)
Inhaled levodopa
Primary Outcome Measure Information:
Title
Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
Description
To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1 (forced expiratory volume in 1 second) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.
Time Frame
Change from baseline at 52 weeks
Title
Pulmonary Safety for CVT-301 Change From Baseline for FVC.
Description
To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FVC, (forced vital capacity) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.
Time Frame
Change from baseline at 52 weeks
Title
Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).
Description
To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1/FVC (FEV1-forced expiratory volume in 1 second and (FVC) forced vital capacity ratio) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.
Time Frame
Change from baseline at 52 weeks
Secondary Outcome Measure Information:
Title
Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
Description
Count of patients achieving resolution of an OFF to an ON state within 60 minutes after study drug is administered in the clinic, and maintaining the ON state at 60 minutes after study drug administration (per the examiner's subjective assessment).
Time Frame
At Treatment Visit - TV6 (Week 52)
Title
Change From Baseline in OFF Time.
Description
Patient reported total daily OFF time and was assessed by the patient and recorded in the patient Diary. An "OFF state" is defined as the time when medication is not providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms. Patients will record their ON and OFF states in their diaries at home.
Time Frame
Change from baseline through 12 months duration of outpatient use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Oh, MD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Acorda Site #5020
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Acorda Site #5042
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Acorda Site #5064
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Acorda Site #5035
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Acorda Site #5027
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Acorda Site #5037
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Acorda Site #5070
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Acorda Site #5047
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
Facility Name
Acorda Site #5068
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Acorda Site #5069
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Acorda Site #5052
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Acorda Site #5046
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Acorda Site #5053
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Acorda Site #5013
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Acorda Site #5016
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Acorda Site #5071
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Acorda Site #5044
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Acorda Site #5060
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Acorda Site #5001
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Acorda Site #5065
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Acorda Site #5012
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Acorda Site #5040
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Acorda Site #5025
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Acorda Site #5030
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Acorda Site #5011
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Acorda Site #5003
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Acorda Site #5067
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Facility Name
Acorda Site #5057
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Acorda Site #5056
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Acorda Site #5018
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Acorda Site #5002
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Acorda Site #5014
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Acorda Site #5041
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Facility Name
Acorda Site #5006
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Acorda Site #5023
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Acorda Site #5028
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Acorda Site #5039
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Acorda Site #5031
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Acorda Site #5032
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Acorda Site #5004
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Acorda Site #5038
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Acorda Site #5048
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Acorda Site #5005
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Acorda Site #5050
City
Norwood
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Acorda Site #5062
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Acorda Site #5036
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Acorda Site #5010
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Acorda Site #5058
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Acorda Site #5022
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Acorda Site #5029
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
372322551
Country
United States
Facility Name
Acorda Site #5019
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Acorda Site #5045
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Acorda Site #5049
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Acorda Site #5059
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Acorda Site #5051
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Acorda Site #5103
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Facility Name
Acorda Site #5104
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4E9
Country
Canada
Facility Name
Acorda Site #5105
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Facility Name
Acorda Site #5201
City
Prague
ZIP/Postal Code
10000
Country
Czechia
Facility Name
Acorda Site #5203
City
Prague
ZIP/Postal Code
14000
Country
Czechia
Facility Name
Acorda Site #5305
City
Gdańsk
State/Province
Zappa
ZIP/Postal Code
80462
Country
Poland
Facility Name
Acorda Site #5304
City
Katowice
ZIP/Postal Code
40588
Country
Poland
Facility Name
Acorda Site #5303
City
Krakow
ZIP/Postal Code
30510
Country
Poland
Facility Name
Acorda Site #5306
City
Kraków
ZIP/Postal Code
30349
Country
Poland
Facility Name
Acorda Site #5307
City
Kraków
ZIP/Postal Code
31505
Country
Poland
Facility Name
Acorda Site #5302
City
Lodz
ZIP/Postal Code
90130
Country
Poland
Facility Name
Acorda Site #5308
City
Warsaw
ZIP/Postal Code
00453
Country
Poland
Facility Name
Acorda Site #5301
City
Warsaw
ZIP/Postal Code
01868
Country
Poland
Facility Name
Acorda Site #5407
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain
Facility Name
Acorda Site #5404
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
Acorda Site #5406
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Acorda Site #5405
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Acorda Site #5403
City
San Sebastián
ZIP/Postal Code
20009
Country
Spain
Facility Name
Acorda Site #5401
City
Sant Cugat Del Vallès
ZIP/Postal Code
08190
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://cvt301.acordatrials.com/en/patient/?src=clinicaltrialsgov004
Description
Click here for more information about this study:CVT-301-004E
Learn more about this trial
Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
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