Evaluating HRG2010 for 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
This study is testing a new treatment called HRG2010 to see if it can help people with Parkinson's Disease manage their motor symptoms better than the usual medication they are taking.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06596876 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical trial is a multicenter, randomized, double-blind, double-dummy, active-controlled study designed to evaluate the efficacy and safety of HRG2010 in patients with Parkinson's Disease who experience motor fluctuations. Participants will be compared against a sustained-release formulation of carbidopa-levodopa. The study aims to determine if HRG2010 can provide better management of motor symptoms compared to the standard treatment. Eligible participants are those aged 40 to 80 who are currently on stable medication regimens but still experience predictable 'Off' periods.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 40 to 80 with Parkinson's Disease experiencing motor fluctuations while on stable treatment.
Not a fit: Patients with atypical or secondary parkinsonism or those who are nonresponsive to levodopa therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve motor control and quality of life for patients with Parkinson's Disease.
How similar studies have performed: Other studies have shown promise in evaluating new treatments for Parkinson's Disease, but the specific approach of HRG2010 is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Shaomin Wei
- Email: shaomin.wei@hengrui.com
- Phone: +0518-81220121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.