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

NCT06236230 | Unknown Phase 4

• 1 other identifier: JD-LK2023062-IR01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Parkinson Disease; levodopa/carbidopa/entacapone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in UPDRS II Score

  Baseline, Week 8

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

  Baseline, Week 8

• Incidence of dyskinesia and wearing off

  Baseline, Week 8

Study Arms (1)

levodopa/carbidopa/entacapone

EXPERIMENTAL

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.

Drug: levodopa/carbidopa/entacapone

Interventions

levodopa/carbidopa/entacapone DRUG

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.

Also known as: Stalevo

levodopa/carbidopa/entacapone

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Shanghai, Shanghai Municipality, 2I5004, China

RECRUITING

Related Publications (6)

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

  PMID: 30178019 BACKGROUND

• 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.

  PMID: 11391738 BACKGROUND

• 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.

  PMID: 28813703 BACKGROUND

• 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.

  PMID: 21437987 BACKGROUND

• 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.

  PMID: 24253234 BACKGROUND

• 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.

  PMID: 19058133 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; Stalevo

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Chun-Feng Liu, MD,PhD

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-feng Liu, MD,PhD

CONTACT

+8613606210609; liuchunfeng@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: November 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)