Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
- Conditions
- Idiopathic Parkinson's Disease
- Interventions
- Drug: CVT-301
- Registration Number
- NCT02242487
- Lead Sponsor
- Acorda Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
- 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 ;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CVT-301 High Dose CVT-301 Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration CVT-301 Low Dose CVT-301 Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
- Primary Outcome Measures
Name Time Method Pulmonary Safety of CVT-301 Change From Baseline for FEV1. Change from baseline at 52 weeks 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. Change from baseline at 52 weeks 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). Change from baseline at 52 weeks 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
Name Time Method Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes. At Treatment Visit - TV6 (Week 52) 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. Change from baseline through 12 months duration of outpatient use 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.
Trial Locations
- Locations (74)
Acorda Site #5013
🇺🇸Boca Raton, Florida, United States
Acorda Site #5040
🇺🇸Atlanta, Georgia, United States
Acorda Site #5025
🇺🇸Chicago, Illinois, United States
Acorda Site #5005
🇺🇸Cleveland, Ohio, United States
Acorda Site #5053
🇺🇸Aventura, Florida, United States
Acorda Site #5042
🇺🇸Fresno, California, United States
Acorda Site #5068
🇺🇸Santa Ana, California, United States
Acorda Site #5027
🇺🇸Long Beach, California, United States
Acorda Site #5020
🇺🇸Scottsdale, Arizona, United States
Acorda Site #5037
🇺🇸Los Angeles, California, United States
Acorda Site #5035
🇺🇸Loma Linda, California, United States
Acorda Site #5301
🇵🇱Warsaw, Poland
Acorda Site #5047
🇺🇸Reseda, California, United States
Acorda Site #5004
🇺🇸New York, New York, United States
Acorda Site #5022
🇺🇸Charleston, South Carolina, United States
Acorda Site #5028
🇺🇸Albany, New York, United States
Acorda Site #5069
🇺🇸Torrance, California, United States
Acorda Site #5016
🇺🇸Jacksonville, Florida, United States
Acorda Site #5104
🇨🇦Ottawa, Ontario, Canada
Acorda Site #5006
🇺🇸Saint Louis, Missouri, United States
Acorda Site #5403
🇪🇸San Sebastián, Spain
Acorda Site #5032
🇺🇸New York, New York, United States
Acorda Site #5010
🇺🇸Philadelphia, Pennsylvania, United States
Acorda Site #5058
🇺🇸Willow Grove, Pennsylvania, United States
Acorda Site #5050
🇺🇸Norwood, Ohio, United States
Acorda Site #5407
🇪🇸Pamplona, Navarre, Spain
Acorda Site #5049
🇺🇸Henrico, Virginia, United States
Acorda Site #5305
🇵🇱Gdańsk, Zappa, Poland
Acorda Site #5307
🇵🇱Kraków, Poland
Acorda Site #5302
🇵🇱Lodz, Poland
Acorda Site #5039
🇺🇸Brooklyn, New York, United States
Acorda Site #5308
🇵🇱Warsaw, Poland
Acorda Site #5018
🇺🇸Boston, Massachusetts, United States
Acorda Site #5023
🇺🇸Las Vegas, Nevada, United States
Acorda Site #5045
🇺🇸Houston, Texas, United States
Acorda Site #5029
🇺🇸Nashville, Tennessee, United States
Acorda Site #5406
🇪🇸Barcelona, Spain
Acorda Site #5405
🇪🇸Madrid, Spain
Acorda Site #5012
🇺🇸Tampa, Florida, United States
Acorda Site #5062
🇺🇸Portland, Oregon, United States
Acorda Site #5046
🇺🇸Atlantis, Florida, United States
Acorda Site #5070
🇺🇸Pasadena, California, United States
Acorda Site #5065
🇺🇸Saint Petersburg, Florida, United States
Acorda Site #5057
🇺🇸Baltimore, Maryland, United States
Acorda Site #5030
🇺🇸Chicago, Illinois, United States
Acorda Site #5003
🇺🇸Kansas City, Kansas, United States
Acorda Site #5014
🇺🇸West Bloomfield, Michigan, United States
Acorda Site #5041
🇺🇸Golden Valley, Minnesota, United States
Acorda Site #5031
🇺🇸New York, New York, United States
Acorda Site #5038
🇺🇸Syracuse, New York, United States
Acorda Site #5019
🇺🇸Houston, Texas, United States
Acorda Site #5203
🇨🇿Prague, Czechia
Acorda Site #5303
🇵🇱Krakow, Poland
Acorda Site #5304
🇵🇱Katowice, Poland
Acorda Site #5306
🇵🇱Kraków, Poland
Acorda Site #5401
🇪🇸Sant Cugat Del Vallès, Spain
Acorda Site #5052
🇺🇸Washington, District of Columbia, United States
Acorda Site #5044
🇺🇸Orlando, Florida, United States
Acorda Site #5059
🇺🇸Virginia Beach, Virginia, United States
Acorda Site #5064
🇺🇸Fullerton, California, United States
Acorda Site #5071
🇺🇸Maitland, Florida, United States
Acorda Site #5001
🇺🇸Port Charlotte, Florida, United States
Acorda Site #5060
🇺🇸Palm Beach Gardens, Florida, United States
Acorda Site #5011
🇺🇸Elk Grove Village, Illinois, United States
Acorda Site #5056
🇺🇸Boston, Massachusetts, United States
Acorda Site #5002
🇺🇸Bingham Farms, Michigan, United States
Acorda Site #5067
🇺🇸Baton Rouge, Louisiana, United States
Acorda Site #5036
🇺🇸Allentown, Pennsylvania, United States
Acorda Site #5051
🇺🇸Kirkland, Washington, United States
Acorda Site #5103
🇨🇦London, Ontario, Canada
Acorda Site #5105
🇨🇦Toronto, Ontario, Canada
Acorda Site #5404
🇪🇸Barcelona, Spain
Acorda Site #5201
🇨🇿Prague, Czechia
Acorda Site #5048
🇺🇸Charlotte, North Carolina, United States