Entacapone added to Madopar (levodopa/benserazide) for early Parkinson's disease: an observational comparison

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

This project will see if adding entacapone to Madopar (levodopa/benserazide) helps people with early Parkinson's disease in China over 24 weeks.

Quick facts

• Study type: Observational
• Enrollment: 216 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Guangxi Medical University (Academic / other)
• Locations: 1 site (Nanning, Guanxi)
• Trial ID: NCT06928519 on ClinicalTrials.gov

What this trial studies

This is a multicenter, observational case-control study in China comparing patients treated with levodopa/benserazide plus entacapone versus levodopa/benserazide alone over 24 weeks. Participants are adults aged 18–80 with early Parkinson's disease (modified Hoehn‑Yahr 1–2.5) who have not previously used entacapone and meet cognitive and mood cutoffs. Treatment group assignment reflects real-world prescribing by the treating physician rather than randomization or blinding. The primary outcome is change in motor signs measured by MDS‑UPDRS Part III, with secondary measures including activities of daily living, motor complications, PDQ‑39 quality of life, MMSE, CGI, and safety/adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults 18–80 with early PD (Hoehn‑Yahr 1–2.5), MMSE ≥26, BDI <15, no prior entacapone use, and either levodopa‑naive or on a stable levodopa dose.

Not a fit: Patients with advanced disease, significant cognitive impairment (MMSE <26), major depression (BDI ≥15), prior entacapone/tolcapone exposure, history of dyskinesia, or unstable levodopa dosing are unlikely to benefit from the findings.

Why it matters

Potential benefit: If successful, adding entacapone could improve motor symptoms and quality of life compared with levodopa/benserazide alone.

How similar studies have performed: COMT inhibitors like entacapone have shown benefit in reducing motor fluctuations in Parkinson's, but evidence specifically supporting routine addition in early, stable levodopa-treated patients is more limited.

Eligibility criteria

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 this trial is running

Nanning, Guanxi

• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guanxi, China (Recruiting)

Study contacts

• Study coordinator: Yousheng Xiao, PhD

Conditions Parkinson Disease; Levodopa; Benserazide; Entacapone