Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes (SPAN-PD™)

Acorda Therapeutics

Status and phase: Completed; Phase 3

Conditions: Idiopathic Parkinson's Disease

Treatments: Drug: CVT-301 High Dose; Drug: CVT-301 Low Dose; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02240030

CVT-301-004

Details and patient eligibility

About

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.

Enrollment: 351 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 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 LD dose <1600 mg/day;
• Able to perform a spirometry maneuver in the ON and OFF states;
• Normal cognition confirmed by MMSE score ≥25

Exclusion criteria

• Pregnant or lactating females;
• Previous surgery for PD or plan to have stereotactic surgery during the study period;
• 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 contraindication to performing routine spirometry.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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351 participants in 3 patient groups, including a placebo group

CVT-301 Low Dose

Experimental group

Description:

Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration

Treatment:

Drug: CVT-301 Low Dose

CVT-301 High Dose

Experimental group

Description:

Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration

Treatment:

Drug: CVT-301 High Dose

Placebo

Placebo Comparator group

Description:

Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.

Treatment:

Other: Placebo