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

Parkinson Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT04191577
• Study type: Interventional
• Source: Cerevance
• Status: Completed
• Phase: Phase 2
• Start date: December 2, 2019
• Completion date: December 13, 2021