Skip to main content
OpenTrials
Completed

NCT Number: NCT06596876

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female who are at age 40~80 years with PD, consistent with the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria and who are being treated with stable regimens of DDCI+LD but experiencing motor fluctuations.
  • Mini Mental State Examination (MMSE) ≥ 24 at Screening Visit.
  • Hoehn and Yahr Stage I-IV when "on" at Screening Visit.
  • At Screening, the participant has predictable "Off" periods.
  • Able and willing to provide a written informed consent.

Exclusion criteria

  • Diagnosed with atypical or secondary parkinsonism.
  • History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage.
  • Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period.
  • Nonresponsive to LD therapy.
  • In the opinion of the clinical investigator, Subjects who should not participate in the study.
  • Subjects who are allergic to the investigational drug to be used in this study.
  • Pregnant or breastfeeding.
  • Participants who have previously participated in an HRG2010 study.

Treatment and study plan

HRG2010; Sustained-release Carbidopa/Levodopa administered placebo

Drug

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

Sustained-release Carbidopa/Levodopa; HRG2010 placebo

Drug

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

Primary outcomes

  1. Change from baseline in "Off" time at Week 21

    Time frame: Last three days collected at the end of treatment period, at Week 21

Secondary outcomes

  1. Change from baseline in "On" Time Without Troublesome Dyskinesia at Week 21

    Time frame: Last three days collected at the end of treatment period, at Week 21

  2. Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Week 21

    Time frame: Week 21

  3. Change from baseline in the 39-item Parkinson's Disease Questionnaire (PDQ-39) at Week 21

    Time frame: Week 21

  4. Adverse events

    Time frame: Week 23

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Controlled, Double-blind, Double-dummy, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.