INTERVENTIONALCOMPLETEDNCT06596876

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

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-08

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE3
Enrollment: 165 (ACTUAL)
Start date: 2024-11-06
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Parkinson Disease

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

HRG2010; Sustained-release Carbidopa/Levodopa administered placebo

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

DRUG

Sustained-release Carbidopa/Levodopa; HRG2010 placebo

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

Eligibility

Population and criteria

Sex: ALL
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: Not accepted

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.

primary outcomes

primary measures

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

secondary measures

Change from baseline in "On" Time Without Troublesome Dyskinesia at Week 21

Time frame: 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

Time frame: Week 21

Change from baseline in the 39-item Parkinson's Disease Questionnaire (PDQ-39) at Week 21

Time frame: Week 21

Adverse events

Time frame: Week 23

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 1ae13cd1-d6cf-44ce-9825-61907e96eac0
Retrieved: 11/09/2026, 14:54:46
SHA-256: dbe14f7401e6ff7e110a1868fc842883bdd53bda59faa6cfe6f6b082a4b4182b