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

PHASE3CompletedINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

May 11, 2020

Primary Completion Date

March 17, 2022

Study Completion Date

September 27, 2022

Conditions
Parkinson Disease
Interventions
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.

Trial Locations (1)

Unknown

Xuanwu Hospital Capital Medical University, Beijing

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Luye Pharma Group Ltd.

INDUSTRY