Parkinson's Trial NCT06928519
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)
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.
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Heart tracing (ECG) (non-invasive). Confirm the full schedule with the study coordinator.