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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236230
• Other study ID #: JD-LK2023062-IR01
• Status: Recruiting
• Phase: Phase 4
• Start date: November 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Second Affiliated Hospital of Soochow University
• Contact: Chun-feng Liu, MD,PhD
• Phone: +8613606210609
• Email: liuchunfeng[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• levodopa/carbidopa/entacapone
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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Soochow University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (6)

Ahlskog JE, Muenter MD. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disord. 2001 May;16(3):448-58. doi: 10.1002/mds.1090. — View Citation

Hauser RA, Auinger P; Parkinson Study Group. Determination of minimal clinically important change in early and advanced Parkinson's disease. Mov Disord. 2011 Apr;26(5):813-8. doi: 10.1002/mds.23638. Epub 2011 Mar 24. — View Citation

Hauser RA, Panisset M, Abbruzzese G, Mancione L, Dronamraju N, Kakarieka A; FIRST-STEP Study Group. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Mov Disord. 2009 Mar 15;24(4):541-50. doi: 10.1002/mds.22343. — View Citation

Homayoun H. Parkinson Disease. Ann Intern Med. 2018 Sep 4;169(5):ITC33-ITC48. doi: 10.7326/AITC201809040. — View Citation

Li J, Lou Z, Liu X, Sun Y, Chen J. Efficacy and Safety of Adjuvant Treatment with Entacapone in Advanced Parkinson's Disease with Motor Fluctuation: A Systematic Meta-Analysis. Eur Neurol. 2017;78(3-4):143-153. doi: 10.1159/000479555. Epub 2017 Aug 16. — View Citation

Tolosa E, Hernandez B, Linazasoro G, Lopez-Lozano JJ, Mir P, Marey J, Kulisevsky J. Efficacy of levodopa/carbidopa/entacapone versus levodopa/carbidopa in patients with early Parkinson's disease experiencing mild wearing-off: a randomised, double-blind trial. J Neural Transm (Vienna). 2014 Apr;121(4):357-66. doi: 10.1007/s00702-013-1114-x. Epub 2013 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 8
Secondary	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.	Baseline, Week 8
Secondary	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.	Baseline, Week 8
Secondary	Incidence of dyskinesia and wearing off	Dyskinesia and wearing off are common motor complications. A motor complications patient questionnaire will be record.	Baseline, Week 8