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A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations

NCT06596876 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-05-02

No results posted yet for this study

Summary

The study is a multicenter, randomized, double-blind, double-dummy, active-controlled, Phase III clinical study. The aim of this trial is to evaluated the efficacy and assessed the safety of HRG2010 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease With Motor Fluctuations.

Conditions

Interventions

DRUG

HRG2010; Sustained-release Carbidopa/Levodopa administered placebo

Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally.

DRUG

Sustained-release Carbidopa/Levodopa; HRG2010 placebo

Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2027-01-31
Completion
2027-02-14

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06596876 on ClinicalTrials.gov