Parkinson's DiseasePhase 3NCT06596876
A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
A Phase 3 study of Parkinson's Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2024to 29 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- HRG2010; Sustained-release Carbidopa/Levodopa administered placebo, Sustained-release Carbidopa/Levodopa; HRG2010 placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRG2010; Sustained-release Carbidopa/Levodopa administered placeboDrug
Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally.
Sustained-release Carbidopa/Levodopa; HRG2010 placeboDrug
Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally.
| Study group | Role | What they receive |
|---|---|---|
| HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo | Experimental | Not described Receives: Drug: HRG2010; Sustained-release Carbidopa/Levodopa administered placebo |
| Sustained-release Carbidopa/Levodopa and HRG2010 placebo | Active comparator | Not described Receives: Drug: Sustained-release Carbidopa/Levodopa; HRG2010 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in "Off" time at Week 21
Measured: 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
Measured: 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
Measured: Week 21
Change from baseline in the 39-item Parkinson's Disease Questionnaire (PDQ-39) at Week 21
Measured: Week 21
Adverse events
Measured: Week 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Nov 2024
- Primary completion9 Oct 2025
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596876
- Sponsor's protocol ID
- HRG2010-301
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06596876
- Acronym / sponsor ID
- HRG2010-301
- Conditions
- Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRG2010; Sustained-release Carbidopa/Levodopa administered placeboSubjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally. | Drug | HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo |
| Sustained-release Carbidopa/Levodopa; HRG2010 placeboSubjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally. | Drug | Sustained-release Carbidopa/Levodopa and HRG2010 placebo |
Primary outcome
Change from baseline in "Off" time at Week 21
Time frame: Last three days collected at the end of treatment period, at Week 21
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Parkinson's Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in "Off" time at Week 21 (time frame: Last three days collected at the end of treatment period, at Week 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.