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
Plain-Language Summary
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.