NCT04571164

A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD

A Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the effictiveness and safety of Ly03003 following intramuscular injections

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	LY03003(Rotigotine,extended-release microspheres)	During the intervention, the initial dose was 14mg, and then was incremented in weekly units, 14mg each time, until the maximum dose of 56mg set in this study was reached 4 weeks after titration, the optimal therapeutic dose or the maximum tolerated dose was entered into the dosing maintenance period. After entering the maintenance period, no dose adjustment was performed, and the stable dose was maintained for 24 weeks
DRUG	Placebo,extended-release microspheres	During the intervention,the initial does was 14mg,and then was incremented in weekly units,14mg each time,until the maximum does of 56mg set in this study was reached 4 weeks after titration,the optimal therapeutic does or the maximum tolerated does was entered into the dosing maintenance period.After entering the maintenance period,no does adjustment was performed,and the stable does was maintained for 24 weeks.

Timeline

• Start date: 2020-05-11
• Primary completion: 2022-03-17
• Completion: 2022-09-27
• First posted: 2020-09-30
• Last updated: 2023-05-06

Locations

1 site across 1 country: China