Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease: An Observational, Multicenter, Case-Control Study
Recruiting · NCT06928519 · Observational (researchers observe without assigning treatment) · Lead sponsor: Yousheng Xiao
View the official record on ClinicalTrials.gov →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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- The First Affiliated Hospital of Guangxi Medical University - Nanning, Guanxi, China