Randomized Safety Study of CVT-301 Compared to an Observational Control Group
- Conditions
- Idiopathic Parkinson's Disease
- Interventions
- Drug: CVT-301Other: Observational cohort
- Registration Number
- NCT02352363
- Lead Sponsor
- Acorda Therapeutics
- Brief Summary
This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.
- Detailed Description
A randomized, double-blind, placebo-controlled, Phase 2b study in patients with PD (CVT-301-003) demonstrated clinically important, and statistically significant CVT-301-associated improvements in motor function at doses of 35 and 50 mg LD FPD, compared with placebo, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) motor assessment (Part 3); furthermore, CVT-301 was generally safe and well tolerated. A Phase 3, randomized, placebo-controlled study designed to assess the efficacy and safety of 35 mg and 50 mg FPD as an adjunct to a CD/LD regimen in the treatment of OFF symptoms over 12 weeks (CVT-301-004) was conducted in parallel with this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 408
- Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed.
- Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
- Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
- Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
- Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.
- Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
- Pregnant or lactating females or females wishing to become pregnant.
- Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma.
- Patients who have had previous surgery for PD (including but not limited to deep brain stimulation [DBS] or cell transplantation).
- Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CVT-301 CVT-301 Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration. Observational Cohort Observational cohort Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.
- Primary Outcome Measures
Name Time Method Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1] Month 12 reported To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second \[FEV1\], over a 12 month period.
Pulmonary Safety Assessed by Forced Vital Capacity [FVC]. Month 12 reported To characterize the pulmonary safety, as assessed by spirometry (forced vital capacity).
Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio. Month 12 reported To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).
- Secondary Outcome Measures
Name Time Method Diffusion Capacity of the Lungs for Carbon Monoxide (DLco). Month 12 reported To describe the effects of CVT-301 on diffusion capacity of the lungs for carbon monoxide (DLco) over a 12-month period.
Trial Locations
- Locations (76)
Acorda Site #7150
🇺🇸Baton Rouge, Louisiana, United States
Acorda Site # 7142
🇺🇸Fountain Valley, California, United States
Acorda Site #7131
🇺🇸Decatur, Georgia, United States
Acorda Site #7118
🇪🇸Madrid, Spain
Acorda Site #7114
🇪🇸Madrid, Spain
Acorda Site #7002
🇦🇹Linz, Austria
Acorda Site #7145
🇺🇸Scottsdale, Arizona, United States
Acorda Site #7048
🇩🇪Bremerhaven, Germany
Acorda Site #7025
🇨🇿Ostrava, Czechia
Acorda Site #7135
🇺🇸Saint Petersburg, Florida, United States
Acorda Site #7024
🇨🇿Chocen, Czechia
Acorda Site #7033
🇫🇷Nimes Cedex, France
Acorda Site #7013
🇧🇪Ghent, Belgium
Acorda Site #7139
🇺🇸Panorama City, California, United States
Acorda Site #7130
🇺🇸Sunrise, Florida, United States
Acorda Site #7049
🇩🇪Berlin, Germany
Acorda Site #7116
🇪🇸Barcelona, Spain
Acorda Site #7032
🇫🇷Strasbourg, France
Acorda Site #7120
🇪🇸Barcelona, Spain
Acorda Site #7021
🇨🇿Pardubice, Czechia
Acorda Site #7003
🇦🇹Vienna, Austria
Acorda Site #7112
🇪🇸Sant Cugat, Barcelona, Spain
Acorda Site #7123
🇬🇧Cambridge, United Kingdom
Acorda Site #7041
🇩🇪Achim, Germany
Acorda Site #7119
🇪🇸Barcelona, Spain
Acorda Site #7103
🇷🇸Kragujevac, Serbia
Acorda Site #7121
🇬🇧Glasgow, United Kingdom
Acorda Site #7082
🇵🇱Lodz, Poland
Acorda Site #7035
🇫🇷Toulouse Cedex 9, France
Acorda Site #7133
🇺🇸Atlanta, Georgia, United States
Acorda Site #7134
🇺🇸Atlanta, Georgia, United States
Acorda Site #7042
🇩🇪Munich, Germany
Acorda Site #7141
🇺🇸Sunnyvale, California, United States
Acorda Site #7137
🇺🇸Ormond Beach, Florida, United States
Acorda Site #7148
🇺🇸Toledo, Ohio, United States
Acorda Site #7011
🇧🇪Brussels, Belgium
Acorda Site #7138
🇺🇸Honolulu, Hawaii, United States
Acorda Site #7140
🇺🇸Des Moines, Iowa, United States
Acorda Site #7004
🇦🇹Innsbruck, Austria
Acorda Site #7012
🇧🇪Edegem, Belgium
Acorda Site #7022
🇨🇿Prague 10, Czechia
Acorda Site #7023
🇨🇿Rychnov nad Kneznou, Czechia
Acorda Site #7037
🇫🇷Bordeaux, France
Acorda Site #7031
🇫🇷MONTPELLIER Cedex 5, France
Acorda Site #7036
🇫🇷Amiens, France
Acorda Site #7034
🇫🇷Marseille Cedex 05, France
Acorda Site #7043
🇩🇪Beelitz-Heilstätten, Germany
Acorda Site #7050
🇩🇪Bochum, Germany
Acorda Site #7047
🇩🇪Cologne, Germany
Acorda Site #7051
🇭🇺Budapest, Hungary
Acorda Site #7053
🇭🇺Budapest, Hungary
Acorda Site #7046
🇩🇪Marburg, Germany
Acorda Site #7044
🇩🇪Ulm, Germany
Acorda Site #7045
🇳🇱Den Haag, Netherlands
Acorda Site #7061
🇮🇱Ramat Gan, Israel
Acorda Site #7062
🇮🇱Jerusalem, Israel
Acorda Site #7064
🇮🇱Petah Tikva, Israel
Acorda Site #7063
🇮🇱Tel-Aviv, Israel
Acorda Site #7084
🇵🇱Katowice, Poland
Acorda Site #7086
🇵🇱Kraków, Poland
Acorda Site #7085
🇵🇱Gdansk, Poland
Acorda Site #7083
🇵🇱Kracow, Poland
Acorda Site #7087
🇵🇱Kraków, Poland
Acorda Site #7092
🇷🇴Brasov, Romania
Acorda Site #7081
🇵🇱Warsaw, Poland
Acorda Site #7088
🇵🇱Warsaw, Poland
Acorda Site #7093
🇷🇴Bucharest, Romania
Acorda Site #7101
🇷🇸Belgrade, Serbia
Acorda Site #7111
🇪🇸Barcelona, Spain
Acorda Site #7113
🇪🇸Burgos, Spain
Acorda Site #7122
🇬🇧London, United Kingdom
Acorda Site #7115
🇪🇸San Sebastian, Spain
Acorda Site #7091
🇷🇴Constanta, Romania
Acorda Site #7094
🇷🇴Brasov, Romania
Acorda Site #7095
🇷🇴Targu Mures, Romania
Acorda Site #7102
🇷🇸Belgrade, Serbia