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

NCT04571164 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2023-05-06

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2022-03-17
Completion
2022-09-27

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04571164 on ClinicalTrials.gov