Trials / Recruiting
RecruitingNCT06596876
A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HRG2010; Sustained-release Carbidopa/Levodopa administered placebo | Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally. |
| DRUG | Sustained-release Carbidopa/Levodopa; HRG2010 placebo | Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally. |
Timeline
- Start date
- 2024-11-06
- Primary completion
- 2027-01-31
- Completion
- 2027-02-14
- First posted
- 2024-09-19
- Last updated
- 2025-05-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06596876. Inclusion in this directory is not an endorsement.