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

Phase 4

Recruiting

• Conditions: Parkinson Disease
• Interventions: Drug: levodopa/carbidopa/entacapone

• Registration Number: NCT06236230
• Lead Sponsor: Second Affiliated Hospital of Soochow University

Brief 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.

Study Timeline

• Study Start: 2023-11-15
• Status Verified: 2023-12
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
levodopa/carbidopa/entacapone	levodopa/carbidopa/entacapone	levodopa/carbidopa/entacapone is a combination drug consisting of levodopa, carbidopa, and entacapone. Each tablet contains a 1:4 ratio of carbidopa to levodopa and 200 mg of entacapone. The optimum daily dosage of levodopa/carbidopa/entacapone must be determined by careful titration in each patient.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) III Score	Baseline, Week 8	The UPDRS is a standardized assessment scale used to measure the patient's disease state. UPDRS Part III measures the motor function of the patient. A higher score indicates greater disability.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in UPDRS II Score	Baseline, Week 8	The UPDRS is a standardized assessment scale used to measure the patient's disease state. UPDRS Part II measures the patient's activities of daily living. A higher score indicates greater disability.
Incidence of dyskinesia and wearing off	Baseline, Week 8	Dyskinesia and wearing off are common motor complications. A motor complications patient questionnaire will be record.
Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)	Baseline, Week 8	The PDQ-39 instrument is used to assess quality of life in individuals with PD. A lower score indicates better quality of life.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Soochow University; 🇨🇳 Shanghai, Shanghai, China