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
Overview
- Phase
- Phase 3
- Intervention
- CVT-301
- Conditions
- Idiopathic Parkinson's Disease
- Sponsor
- Acorda Therapeutics
- Enrollment
- 408
- Locations
- 76
- Primary Endpoint
- Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
CVT-301
Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.
Intervention: CVT-301
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.
Intervention: Observational cohort
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).(Month 12 reported)