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 27, 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352363
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|Study Director:||Charles Oh, MD||Acorda Therapeutics|