Studies entacapone with Madopar in early Parkinson's disease patients
Observes whether adding entacapone to Madopar helps people with early Parkinson's disease.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease: An Observational, Multicenter, Case-Control Study
Key facts
- Where
- Nanning, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06928519, who can take part
Where in China
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yousheng Xiao
- Trial code
- NCT06928519
- Record updated
- 24 June 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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; BDI score ≥ 15; MMSE score < 26; Unstable levodopa dosage.