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

Study First Received, September 21,2020
Lead Sponsor: Luye Pharma Group Ltd. (Funder Type: Industry)
Conditions
Parkinson Disease
Interventions
Drug: LY03003(Rotigotine,extended-release microspheres)Drug: Placebo,extended-release microspheres
Study Type
Interventional
Phase
Phase 3
Status
ongoing, recruiting (294 patients)
Study Duration
2020-05-11 to 2022-05-31
Overview Outcomes Eligibility Locations Investigators No Results
Overview
Official Title
A Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD

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

Arms
LY03003 Experimental
Placebo Placebo Comparator

Funder Type
Industry

Lead Sponsor
Luye Pharma Group Ltd.

Collaborators
Parexel (Industry)

First Received
2020-09-21

Last Updated
2020-09-25

Start Date
2020-05-11

Primary Completion
2021-12-31

Completion Date
2022-05-31

NCT Identifie
NCT04571164

Contact Information
Shuren Guo Guo, 13501029003, guoshuren@luye.com

Outcomes
Eligibility
Locations
Investigators
No Results