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New Parkinson's drug aims to smooth out 'Off' episodes

NCT ID NCT06596876

Disease control Sponsor: Jiangsu HengRui Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested a new drug called HRG2010 in 165 people with Parkinson's disease who experience motor fluctuations—times when their symptoms return before the next dose. The study compared HRG2010 to a standard sustained-release levodopa to see if it could reduce daily 'off' time (when movement is poor) and improve quality of life. Results will show whether this new formulation offers better symptom control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HRG2010 (a new formulation of carbidopa/levodopa)
What this could lead to
If it works, this could offer a better way to manage motor fluctuations in Parkinson's disease, giving patients more stable symptom control throughout the day.
What could go wrong
This is a single phase 3 study with 165 participants, so results may not apply to all Parkinson's patients. The new drug may not prove significantly better than existing sustained-release levodopa, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

165 people

The number who actually took part.

Started

Nov 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson's disease

Contacts and locations

Locations

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.