---
title: Reduce predictable off time episodes
nct_id: NCT06596876
phase: PHASE3
status: RECRUITING
sponsor: Jiangsu HengRui Medicine Co., Ltd.
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06596876"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06596876"
last_fetched: "2026-05-10T14:02:34.716Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce predictable off time episodes

**Goal (in five words):** Reduce predictable off time episodes

**Official Title:** 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

**Trial ID:** [NCT06596876](https://clinicaltrials.gov/study/NCT06596876)

## Key Facts

- **Phase:** PHASE3
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Jiangsu HengRui Medicine Co., Ltd.
- **Target Enrollment:** 450 participants
- **Start Date:** 2024-11-06
- **Completion Date:** 2027-01-31
- **Conditions:** Parkinson's Disease
- **Interventions:** HRG2010; Sustained-release Carbidopa/Levodopa administered placebo, Sustained-release Carbidopa/Levodopa; HRG2010 placebo
- **Intervention Types:** DRUG

## Summary For Families

Researchers are testing whether HRG2010 can reduce the predictable "Off" time and other motor fluctuations that happen as levodopa wears off. HRG2010 is a new oral medication thought to control motor symptoms by a different mechanism than levodopa, and in this trial it is being compared head-to-head with sustained-release carbidopa/levodopa using a double-blind, double-dummy design so each person gets one active drug and a matching placebo; the goal is to see if HRG2010 smooths movement without needing higher levodopa doses or adding levodopa side effects. The trial seeks adults 40 to 80 years old who meet Parkinson's criteria, are on a stable dopa-decarboxylase inhibitor plus levodopa regimen, have predictable Off periods, MMSE 24 or higher, and are Hoehn and Yahr stage I,IV when "on." People with atypical parkinsonism, prior functional neurosurgery like DBS, nonresponse to levodopa, certain gastrointestinal or eye conditions, pregnancy, or prior HRG2010 study participation are excluded.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full 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.
```

## Locations (1)

- Beijing Hospital, Beijing, Beijing Municipality, China _(39.9075, 116.3972)_
  - Haibo Chen — (CONTACT)

## Central Contacts

- Shaomin Wei — (CONTACT) — +0518-81220121 — shaomin.wei@hengrui.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT06596876*  
*HTML version: https://parkinsonspathways.com/trial/NCT06596876*  
*Source data: https://clinicaltrials.gov/study/NCT06596876*