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

NCT06236230•Second Affiliated Hospital of Soochow University

Summary

This is a, open-label, single-arm 8-week investigation of levodopa/carbidopa/entacapone in the treatment of early Parkinson's disease.

Detailed Description

This study will enroll subjects who have a diagnosis of PD with Hoehn-Yahr stage 1.5-3.0 and assess the impact of low dosage of levodopa/carbidopa/entacapone treatment on the motor function and quality of life among PD patients.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The Second Affiliated Hospital of Soochow University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

November 15, 2023

Primary Completion Date

June 30, 2024

Completion Date

December 31, 2024

Last Updated

February 1, 2024

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

levodopa/carbidopa/entacapone

DRUG

Contacts

Chun-feng Liu, MD,PhD

CONTACT

+8613606210609 liuchunfeng@suda.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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