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

Phase 3

Recruiting

• Conditions: Parkinson's Disease
• Interventions: Drug: Sustained-release Carbidopa/Levodopa; HRG2010 placebo; Drug: HRG2010; Sustained-release Carbidopa/Levodopa administered placebo

• Registration Number: NCT06596876
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-19
• Study Start: 2024-11-06
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2027-01-31
• Study Completion: 2027-02-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sustained-release Carbidopa/Levodopa and HRG2010 placebo	Sustained-release Carbidopa/Levodopa; HRG2010 placebo	-
HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo	HRG2010; Sustained-release Carbidopa/Levodopa administered placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in "Off" time at Week 21	Last three days collected at the end of treatment period, at Week 21

Secondary Outcome Measures

Name	Time	Method
Change from baseline in "On" Time Without Troublesome Dyskinesia at Week 21	Last three days collected at the end of treatment period, at Week 21
Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Week 21	Week 21
Change from baseline in the 39-item Parkinson's Disease Questionnaire (PDQ-39) at Week 21	Week 21
Adverse events	Week 23

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China