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

NCT06928519 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 216

Last updated 2025-06-24

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease (PD)

Sponsors & Collaborators

  • Jiangbin Hospital of Guangxi Zhuang Autonomous Region

    collaborator UNKNOWN

  • Guangxi International Zhuang Medicine Hospital

    collaborator UNKNOWN

  • Ethnic Hospital of Guangxi Zhuang Autonomous Region

    collaborator UNKNOWN

  • Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University

    collaborator UNKNOWN

  • Yousheng Xiao

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2027-04-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06928519 on ClinicalTrials.gov