NCT06596876CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
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
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 165 (actual)
- First submitted
- 11 Sept 2024
- Start date
- 6 Nov 2024
- Primary completion date
- 9 Oct 2025
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Parkinson disease
- NCT number
- NCT06596876
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 165
- From 6 Nov 2024 to the primary completion date, 9 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period.
- Nonresponsive to LD therapy.
- Subjects who are allergic to the investigational drug to be used in this study.
- Participants who have previously participated in an HRG2010 study.
Other illness
- History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage.
Other
- Diagnosed with atypical or secondary parkinsonism.
- In the opinion of the clinical investigator, Subjects who should not participate in the study.
- Pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.