Reduce predictable off time episodes
- Trial ID
- NCT06596876
- 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
- Goal
- Reduce predictable off time episodes
- Phase
- PHASE3
- Status
- RECRUITING
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 450 participants
- Conditions
- Parkinson's Disease
- Interventions
- HRG2010; Sustained-release Carbidopa/Levodopa administered placebo, Sustained-release Carbidopa/Levodopa; HRG2010 placebo
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.
Locations
- Beijing Hospital, Beijing, Beijing Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying HRG2010; Sustained-release Carbidopa/Levodopa administered placebo. 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.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 2 years and 3 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.