Randomized Safety Study of CVT-301 Compared to an Observational Control Group
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|ClinicalTrials.gov Identifier: NCT02352363|
Recruitment Status : Completed
First Posted : February 2, 2015
Results First Posted : July 10, 2018
Last Update Posted : May 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Parkinson's Disease||Drug: CVT-301 Other: Observational cohort||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||408 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.
Other Name: Inhaled levodopa
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.
Other: Observational cohort
- Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1] [ Time Frame: 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]. [ Time Frame: 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. [ Time Frame: Month 12 reported ]To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).
- Diffusion Capacity of the Lungs for Carbon Monoxide (DLco). [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352363
|Study Director:||Charles Oh, MD||Acorda Therapeutics|