NCT04191577

Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Cerevance Beta, Inc. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study, randomized, double-blind, placebo-controlled, multicenter study of oral CVN424 at two dose levels (low-dose and high-dose) in Parkinson's disease (PD) patients with motor fluctuations.

Detailed description

Approximately 135 male and female subjects with Parkinson's disease, on a stable dosage of levodopa but with an average of ≥ 2 h total OFF time/day and not less than 1 h per day, will be enrolled. Following baseline safety and efficacy assessments, subjects will be randomized to receive once-daily doses of either low-dose CVN424, high-dose CVN424, or matching placebo. All subjects not randomized to placebo will initiate treatment with a low-dose of CVN424 on Day 1; the low-dose arm will continue to receive their low dose each day, while the high-dose arm will increase their daily dosage to the high-dose CVN424 beginning on Day 8 ±2 days and continuing thereafter. Study drug will be self-administered each morning as an oral suspension. Subjects will continue their other PD medications.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	CVN424 Low Dose	CVN424
DRUG	CVN424 High Dose	CVN424
DRUG	Placebo	Placebo

Timeline

• Start date: 2019-12-02
• Primary completion: 2021-11-06
• Completion: 2021-12-13
• First posted: 2019-12-10
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study