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

Soochow University

Status and phase: Enrolling; Phase 4

Conditions: Parkinson Disease

Treatments: Drug: levodopa/carbidopa/entacapone

Study type: Interventional

Funder types: Other

Identifiers

NCT06236230

JD-LK2023062-IR01

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

levodopa/carbidopa/entacapone

Experimental group

Description:

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.

Treatment:

Drug: levodopa/carbidopa/entacapone