Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
Primary Purpose
Idiopathic Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CVT-301
Placebo
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 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:
- 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;
- 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.
Sites / Locations
- Civitas Investigational Site 1013
- Civitas Investigational Site 1004
- Civitas Investigational Site 1002
- Civitas Investigational Site 1015
- Civitas Investigational Site 1007
- Civitas Investigational Site 1010
- Civitas Investigational Site 1001
- Civitas Investigational Site 1008
- Civitas Investigational Site 1009
- Civitas Investigational Site 1005
- Civitas Investigational Site 1011
- Civitas Investigational Site 1014
- Civitas Investigational Site 1003
- Civitas Investigational Site 4003
- Civitas Investigational Site 4002
- Civitas Investigational Site 4001
- Civitas Investigational Site 3001
- Civitas Investigational Site 3002
- Civitas Investigational Site 2004
- Civitas Investigational Site 200
- Civitas Investigational Site 2001
- Civitas Investigational Site 2003
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CVT-301
Inhaled Placebo
Arm Description
CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment.
Subjects randomized to receive placebo in a 1:1 randomization scheme
Outcomes
Primary Outcome Measures
Change in average Unified Parkinson's Disease Rating Scale Part III motor score
Secondary Outcome Measures
Time to resolution of OFF episode to an ON state.
To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.
Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01777555
Brief Title
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
Official Title
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled 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
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVT-301
Arm Type
Experimental
Arm Description
CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment.
Arm Title
Inhaled Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to receive placebo in a 1:1 randomization scheme
Intervention Type
Drug
Intervention Name(s)
CVT-301
Other Intervention Name(s)
Levodopa Inhalation Powder
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in average Unified Parkinson's Disease Rating Scale Part III motor score
Time Frame
pre-dose to 60 minutes following treatment
Secondary Outcome Measure Information:
Title
Time to resolution of OFF episode to an ON state.
Time Frame
28 days duration outpatient treatment
Title
To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.
Description
Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry
Time Frame
change from baseline through 28 days outpatient use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 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 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:
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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Freed, MD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Civitas Investigational Site 1013
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Civitas Investigational Site 1004
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33427
Country
United States
Facility Name
Civitas Investigational Site 1002
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33948
Country
United States
Facility Name
Civitas Investigational Site 1015
City
Tampa
State/Province
Florida
ZIP/Postal Code
33601
Country
United States
Facility Name
Civitas Investigational Site 1007
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66101
Country
United States
Facility Name
Civitas Investigational Site 1010
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02108
Country
United States
Facility Name
Civitas Investigational Site 1001
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Civitas Investigational Site 1008
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
Civitas Investigational Site 1009
City
Saint Louis
State/Province
Michigan
ZIP/Postal Code
48880
Country
United States
Facility Name
Civitas Investigational Site 1005
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Civitas Investigational Site 1011
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Civitas Investigational Site 1014
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44101
Country
United States
Facility Name
Civitas Investigational Site 1003
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Civitas Investigational Site 4003
City
Cassino
Country
Italy
Facility Name
Civitas Investigational Site 4002
City
Chieti
Country
Italy
Facility Name
Civitas Investigational Site 4001
City
Rome
Country
Italy
Facility Name
Civitas Investigational Site 3001
City
Belgrade
Country
Serbia
Facility Name
Civitas Investigational Site 3002
City
Belgrade
Country
Serbia
Facility Name
Civitas Investigational Site 2004
City
Cambridge
Country
United Kingdom
Facility Name
Civitas Investigational Site 200
City
Glasgow
Country
United Kingdom
Facility Name
Civitas Investigational Site 2001
City
London
Country
United Kingdom
Facility Name
Civitas Investigational Site 2003
City
Stoke on Trent
Country
United Kingdom
12. IPD Sharing Statement
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Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
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