Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acorda Therapeutics
• Treatments: Levodopa

Criteria

Inclusion Criteria:

• 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 ;

Exclusion Criteria:

• 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.