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

NCT06596876 | Completed Phase 3

• 1 other identifier: HRG2010-301
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in "Off" time at Week 21

  Last three days collected at the end of treatment period, at Week 21

Secondary Outcomes (4)

• 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

Study Arms (2)

HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo

EXPERIMENTAL

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

Sustained-release Carbidopa/Levodopa and HRG2010 placebo

ACTIVE COMPARATOR

Drug: Sustained-release Carbidopa/Levodopa; HRG2010 placebo

Interventions

HRG2010; Sustained-release Carbidopa/Levodopa administered placebo DRUG

Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally.

HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo

Sustained-release Carbidopa/Levodopa; HRG2010 placebo DRUG

Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally.

Sustained-release Carbidopa/Levodopa and HRG2010 placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: November 6, 2024
• Primary Completion: October 9, 2025
• Study Completion: January 29, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

CN (1)