Clinical trial NCT06236230: Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease
Official title: Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Parkinson Disease
Keywords: Parkinson Disease
levodopa/carbidopa/entacapone
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) III Score
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in UPDRS II Score
timeFrame: Baseline, Week 8
measure: Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline, Week 8
measure: Incidence of dyskinesia and wearing off
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Shanghai
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Chun-Feng Liu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Homayoun H. Parkinson Disease. Ann Intern Med. 2018 Sep 4;169(5):ITC33-ITC48. doi: 10.7326/AITC201809040.
citation: 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.
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.
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.
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.
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.