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

Second Affiliated Hospital of Soochow University60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

levodopa/carbidopa/entacaponeDRUG

On Day 1, subjects will be treated with levodopa/carbidopa/entacapone. Based on previous regimen. The dosage of levodopa/carbidopa/entacapone will be equal to the previous total daily dose of LD, and the frequency of administration of levodopa/carbidopa/entacapone is three or four times a day. Levodopa/carbidopa/entacapone could be titrated in next 2 weeks according to the investigator's judgment, based on individual clinical response and tolerability. After 2-week titration, the dose of levodopa/carbidopa/entacapone will remain as constant as possible to the end of study.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

RECRUITING

Outcomes

Primary Outcomes

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) III Score

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.

Time frame: Baseline, Week 8

Secondary Outcomes

Change From Baseline in UPDRS II Score

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.

Time frame: Baseline, Week 8

Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)

The PDQ-39 instrument is used to assess quality of life in individuals with PD. A lower score indicates better quality of life.

Time frame: Baseline, Week 8

Incidence of dyskinesia and wearing off

Dyskinesia and wearing off are common motor complications. A motor complications patient questionnaire will be record.

Time frame: Baseline, Week 8

Central Contacts

Chun-feng Liu, MD,PhD

CONTACT

+8613606210609 liuchunfeng@suda.edu.cn

Data from ClinicalTrials.gov

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