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

Acorda Therapeutics

Status and phase: Completed; Phase 3

Conditions: Idiopathic Parkinson's Disease

Treatments: Drug: CVT-301

Study type: Interventional

Funder types: Industry

Identifiers

NCT02242487

CVT-301-004E

Details and patient eligibility

About

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.

Enrollment: 325 patients

Sex: All

Ages: 30 to 86 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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325 participants in 2 patient groups

CVT-301 Low Dose

Experimental group

Description:

Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration

Treatment:

Drug: CVT-301

CVT-301 High Dose

Experimental group

Description:

Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration

Treatment:

Drug: CVT-301