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