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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country450 target enrollmentNovember 6, 2024

InterventionsHRG2010; Sustained-release Carbidopa/Levodopa administered placebo Sustained-release Carbidopa/Levodopa; HRG2010 placebo

DrugsHRG2010; Sustained-release Carbidopa/Levodopa administered placebo Sustained-release Carbidopa/Levodopa; HRG2010 placebo

Overview

Phase: Phase 3
Intervention: HRG2010; Sustained-release Carbidopa/Levodopa administered placebo
Conditions: Parkinson's Disease
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 450
Locations: 1
Primary Endpoint: Change from baseline in "Off" time at Week 21
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 6, 2024

End Date

February 14, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo

Intervention: HRG2010; Sustained-release Carbidopa/Levodopa administered placebo

Sustained-release Carbidopa/Levodopa and HRG2010 placebo

Intervention: Sustained-release Carbidopa/Levodopa; HRG2010 placebo

Outcomes

Primary Outcomes

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

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)