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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Yousheng Xiao, PhD
• Email: xys135@126.com
• Phone: +86-15177196935

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Parkinson’s Risk in Gaucher Disease Type 1

  This study tests how Parkinson’s risk relates to GBA1-related Gaucher disease in adults over 40, by collecting detailed clinical data and samples for future research.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT07886879

• Can the Ronnie Gardiner Method improve thinking and daily function in people with Parkinson’s

  In this 10-week program, adults with Parkinson’s disease will try the Ronnie Gardiner Method to see if it helps thinking, talking, movement, balance, and quality of life.

  Recruiting University Ghent · Ghent, Oost-Vlaanderen · NCT07863219

• Effects of excitatory and inhibitory LIFUS of GPi in Parkinson’s patients without DBS

  This study tests two deep-brain focused ultrasound patterns on people with Parkinson’s to see if they change task performance and tremor, compared with a sham stimulation.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07846007

• Capacitive-resistive radiofrequency therapy for people with Parkinson's disease

  This study tests four TECAR therapy protocols on the legs to see which best reduces muscle stiffness and improves walking in people with Parkinson's disease.

  Recruiting Universidad San Jorge · Zaragoza, Zaragoza · NCT07842926

• TRB-001 safety and immune response in early Parkinson's disease

  This early-phase study tests TRB-001 against placebo to see if it is safe and prompts an immune response in people with recently diagnosed Parkinson’s disease.

  Recruiting Phase 1 Tridem Bioscience FlexCo · Vienna · NCT07840027

• Bayesian optimization to tune DBS for better gait in Parkinson’s patients

  This study tests whether using Bayesian optimization can quickly find DBS settings that lengthen step length in people with Parkinson's who already have DBS in place.

  Recruiting Early Phase 1 University of Minnesota · Minneapolis, Minnesota · NCT07835308

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.