Reduce medication wearing off fluctuations

Trial ID
NCT06928519
Official Title
Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease: An Observational, Multicenter, Case-Control Study
Goal
Reduce medication wearing off fluctuations
Status
RECRUITING
Sponsor
Yousheng Xiao
Study Type
OBSERVATIONAL
Enrollment
216 participants
Conditions
Parkinson Disease (PD)

Plain-Language Summary

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.

Locations

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

Frequently Asked Questions

What is this trial testing?
This trial is studying an experimental treatment. 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.
Who can participate?
Participants must be between 18 Years and 80 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 1 year and 11 months.

View on ClinicalTrials.gov