Status:
RECRUITING
Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease: An Observational, Multicenter, Case-Control Study
Lead Sponsor:
Yousheng Xiao
Collaborating Sponsors:
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Guangxi International Zhuang Medicine Hospital
Conditions:
Parkinson Disease (PD)
Eligibility:
All Genders
18-80 years
Brief Summary
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 dise...
Detailed Description
This is an observational, multicenter, case-control study designed to evaluate the efficacy and safety of Entacapone combined with Madopar (Levodopa/Benserazide, LB) in the treatment of early-stage Pa...
Eligibility Criteria
Inclusion
- Age between 18 and 80 years;
- Diagnosed with Parkinson's Disease based on the 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 ≥ 26;
- BDI (Beck Depression Inventory) score \< 15;
- Either:
- Has never used levodopa before, or
- Has been on a stable dose of levodopa (300-600 mg/day) for at least 1 month prior to enrollment;
- Stable doses of amantadine, anticholinergics, dopamine agonists, selegiline, or rasagiline are allowed if maintained for at least 30 days prior to and during the study;
- Willing and able to give informed consent and comply with study procedures, with caregiver support if needed.
Exclusion
- 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 ≥ 15;
- MMSE score \< 26;
- Unstable levodopa dosage;
- History of dyskinesia;
- Diagnosis of atypical or secondary parkinsonism, or history of PD-related neurosurgery;
- Clinically significant medical conditions within the past 5 years that could interfere with study participation;
- Use of medications known to induce parkinsonism;
- Participation in other investigational drug trials within 30 days before baseline.
Key Trial Info
Start Date :
June 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT06928519
Start Date
June 5 2025
End Date
June 30 2027
Last Update
June 24 2025
Active Locations (1)
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1
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guanxi, China, 530021