NCT06596876 A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
| NCT ID | NCT06596876 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-11-06 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 450 participants in total. It began in 2024-11-06 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Mini Mental State Examination (MMSE) ≥ 24 at Screening Visit. 3. Hoehn and Yahr Stage I-IV when "on" at Screening Visit. 4. At Screening, the participant has predictable "Off" periods. 5. Able and willing to provide a written informed consent. Exclusion Criteria: 1. Diagnosed with atypical or secondary parkinsonism. 2. History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage. 3. Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period. 4. Nonresponsive to LD therapy. 5. In the opinion of the clinical investigator, Subjects who should not participate in the study. 6. Subjects who are allergic to the investigational drug to be used in this study. 7. Pregnant or breastfeeding. 8. Participants who have previously participated in an HRG2010 study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06596876 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06596876 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 450 participants.
Is NCT06596876 currently recruiting?
Yes, NCT06596876 is actively recruiting participants. Contact the research team at shaomin.wei@hengrui.com for enrollment information.
Where is the NCT06596876 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06596876 clinical trial?
NCT06596876 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 450 participants.
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