Search / Trial NCT06236230

Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease

Launched by SECOND AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jan 24, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Parkinson Disease Levodopa/Carbidopa/Entacapone

ClinConnect Summary

This clinical trial is exploring the effectiveness of a combination medication called levodopa/carbidopa/entacapone in treating early Parkinson's disease. It is an 8-week study where researchers will observe how well this treatment helps improve symptoms for people who have just been diagnosed with Parkinson's. The trial is open to both men and women aged 30 to 80 who have early-stage Parkinson's disease and are not currently taking any Parkinson's medications or have been stable on their current medications for at least 30 days.

To participate, individuals must not have other forms of Parkinson's disease, such as atypical or drug-induced Parkinsonism, and should not have a history of certain health conditions, like severe cognitive impairment or recent surgeries. Participants in this study can expect to receive the medication for the full duration of the trial, and they will be monitored closely by researchers to assess its effects. Overall, this trial aims to provide valuable information about how this medication can help improve the quality of life for those newly diagnosed with Parkinson's disease.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male or female and greater from 30 to 80.
  • Diagnosis of idiopathic PD according to the MDS PD Diagnostic Criteria (2015).
  • Hoehn-Yahr stage of 1.5-3.0 ("open" stage).
  • Not on anti-PD medication or stable on anti-PD medication for at least 30 days.
  • Exclusion Criteria:
  • Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.
  • History of surgery within 6 months.
  • Alcoholism, drug abuse, or severe cognitive impairment (including severe Alzheimer's disease)
  • Psychiatric illness, epilepsy, pregnancy and breastfeeding, and clinically significant concomitant illnesses
  • Participation in another clinical trial within 2 months.
  • With dyskinesia.
  • Any other condition that, in the opinion of the investigator, makes them ineligible for enrolment.

Trial Officials

Chun-Feng Liu, MD,PhD

Principal Investigator

Second Affiliated Hospital of Soochow University

About Second Affiliated Hospital Of Soochow University

The Second Affiliated Hospital of Soochow University is a leading medical institution in China, renowned for its commitment to advanced healthcare and clinical research. As a prominent sponsor of clinical trials, the hospital leverages its extensive expertise in various medical fields to facilitate innovative treatments and improve patient outcomes. With a multidisciplinary team of experienced clinicians and researchers, the institution aims to contribute to the global medical community by advancing evidence-based practices and fostering collaborations that enhance therapeutic options. Through rigorous trial management and adherence to ethical standards, the Second Affiliated Hospital is dedicated to enhancing the quality of care and driving medical advancements.

Locations

Shanghai, Shanghai, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0