Actively Recruiting
Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease: An Observational, Multicenter, Case-Control Study
Led by Yousheng Xiao · Updated on 2025-06-24
216
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
Y
Yousheng Xiao
Lead Sponsor
J
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Collaborating Sponsor
AI-Summary
What this Trial Is About
This observational, multicenter, case-control study aims to evaluate the efficacy and safety of Entacapone combined with Madopar (levodopa/benserazide) in the treatment of early-stage Parkinson's disease (PD) among Chinese patients. The study will enroll patients diagnosed with PD according to the MDS criteria, aged 18-80, with modified Hoehn-Yahr stages 1-2.5, and who have not previously used Entacapone. Participants will be assigned to two groups based on their prior treatment history: the LBE group (levodopa/benserazide/entacapone) or the LB group (levodopa/benserazide only), according to their actual clinical treatment plan. The study will observe patients over a 24-week period, evaluating changes in motor symptoms using the MDS-UPDRS Part III score as the primary endpoint. Secondary outcomes include assessments of daily living abilities, motor complications, quality of life (PDQ-39), cognitive function (MMSE), global impression (CGI), and safety profiles, including adverse event reporting. This study does not involve any interventional treatment changes; all therapeutic decisions remain at the discretion of the treating physicians. The findings are expected to provide real-world evidence regarding the potential benefits and safety of adding Entacapone to Madopar in the management of early PD.
CONDITIONS
Official Title
Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease: An Observational, Multicenter, Case-Control Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed with Parkinson's Disease based on MDS criteria confirmed by a movement disorder neurologist
- Modified Hoehn and Yahr stage between 1 and 2.5
- No prior use of entacapone
- MMSE score of 26 or higher
- Beck Depression Inventory (BDI) score less than 15
- Either never used levodopa or on a stable levodopa dose (300-600 mg/day) for at least 1 month before enrollment
- Stable doses of amantadine, anticholinergics, dopamine agonists, selegiline, or rasagiline for at least 30 days before and during the study
- Willing and able to give informed consent and comply with study procedures, with caregiver support if needed
You will not qualify if you...
- Previous use of entacapone or tolcapone for more than 30 days or within 4 weeks before baseline
- Use of dopamine agonists within 4 weeks before baseline
- BDI score of 15 or higher
- MMSE score below 26
- Unstable levodopa dosage
- History of dyskinesia
- Diagnosis of atypical or secondary parkinsonism or history of PD-related neurosurgery
- Significant medical conditions in the past 5 years that could interfere with participation
- Use of medications known to induce parkinsonism
- Participation in other investigational drug trials within 30 days before baseline
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guanxi, China, 530021
Actively Recruiting
Research Team
Y
Yousheng Xiao, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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