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

Launched by YOUSHENG XIAO · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called entacapone when combined with Madopar (a treatment containing levodopa) for people with early Parkinson's disease (PD). Levodopa is the most common and effective medicine for managing PD symptoms, but it can cause issues over time. Entacapone helps make the effects of levodopa last longer and more stable, which could lead to better control of symptoms. The study will involve two groups: one will receive only Madopar, while the other will receive both Madopar and entacapone. Participants will be treated for 24 weeks, and the researchers will measure changes in motor symptoms, daily living abilities, quality of life, and safety throughout the trial.

To be eligible for this study, participants should be between 18 and 80 years old and have a confirmed diagnosis of early Parkinson's disease. They should either have never taken levodopa before or have been on a stable dose for at least a month prior to joining the study. Participants will need to have a good understanding of their condition and be able to follow study procedures, with help from a caregiver if needed. Importantly, those with a history of certain complications or who have taken specific medications recently may not qualify. This trial is not yet recruiting participants, but it aims to provide valuable information about whether combining these medications can improve treatment outcomes for early-stage Parkinson's disease.

Gender

ALL

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.