RecruitingNCT06928519

Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease: An Observational, Multicenter, Case-Control Study

Sponsor

Yousheng Xiao

Enrollment

216 participants

Start Date

Jun 5, 2025

Study Type

OBSERVATIONAL

Conditions

Parkinson Disease (PD)

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 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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria11

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 Criteria10

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.