NCT06928519Recruiting

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

Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Observational
Enrollment: 216 (estimated)
First submitted: 22 Mar 2025
Start date: 5 Jun 2025
Primary completion date: 30 Apr 2027
Lead sponsor: Yousheng Xiao
Diseases: Parkinson disease
NCT number: NCT06928519

What you commit to

Study type: Observational
Planned participants: 216
From 5 Jun 2025 to the primary completion date, 30 Apr 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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;
Use of medications known to induce parkinsonism;
Participation in other investigational drug trials within 30 days before baseline.

Other illness

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;

Other

BDI score ≥ 15;
MMSE score \< 26;
Unstable levodopa dosage;

Who the study is looking for

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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status	Nanning	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.