---
title: Reduce medication wearing off fluctuations
nct_id: NCT06928519
status: RECRUITING
sponsor: Yousheng Xiao
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06928519"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06928519"
last_fetched: "2026-05-10T14:01:38.116Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce medication wearing off fluctuations

**Goal (in five words):** Reduce medication wearing off fluctuations

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

**Trial ID:** [NCT06928519](https://clinicaltrials.gov/study/NCT06928519)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** Yousheng Xiao
- **Target Enrollment:** 216 participants
- **Start Date:** 2025-06-05
- **Completion Date:** 2027-04-30
- **Conditions:** Parkinson Disease (PD)

## Summary For Families

The goal is to see whether adding entacapone to Madopar (levodopa/benserazide) gives people with early Parkinson's more consistent symptom relief and is safe. Entacapone blocks the COMT enzyme that breaks down levodopa in the body, so when taken with Madopar it prolongs levodopa levels and effect, which can smooth wearing-off but may also amplify levodopa-related side effects, so the study watches both benefits and harms. They are enrolling people 18 to 80 with early PD (Hoehn and Yahr 1,2.5), good cognition and low depression scores, who have never used entacapone and are either levodopa-naive or on a stable levodopa dose of 300,600 mg per day.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full 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.
```

## Locations (1)

- The First Affiliated Hospital of Guangxi Medical University, Nanning, Guanxi, China _(22.8167, 108.3167)_
  - Yousheng Xiao Yousheng Xiao, MD — (CONTACT) — +86 15177196935 — xys135@126.com
  - Yousheng Xiao, MD — (PRINCIPAL_INVESTIGATOR)
  - Binru Li, MMed — (SUB_INVESTIGATOR)
  - Huadan Yang, MMed — (SUB_INVESTIGATOR)
  - Li Wang, MD — (SUB_INVESTIGATOR)
  - Huaxin Huang, MBBS — (SUB_INVESTIGATOR)
  - Lingyue Liang, MBBS — (SUB_INVESTIGATOR)
  - Jiang Lei, MMed — (SUB_INVESTIGATOR)

## Central Contacts

- Yousheng Xiao, PhD — (CONTACT) — +86-15177196935 — xys135@126.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT06928519*  
*HTML version: https://parkinsonspathways.com/trial/NCT06928519*  
*Source data: https://clinicaltrials.gov/study/NCT06928519*