Parkinson Disease
Conditions
Keywords
Parkinson Disease, levodopa/carbidopa/entacapone
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.
Interventions
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.
Sponsors
Second Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactChun-feng Liu, MD,PhD
Outcome results
None listed