Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease: An Observational, Multicenter, Case-Control Study

NCT06928519 | Recruiting

• 1 other identifier: EMPD-001
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

This observational, multicenter, case-control study aims to evaluate the efficacy and safety of Entacapone combined with Madopar (levodopa/benserazide) in the treatment of early-stage Parkinson's disease (PD) among Chinese patients. The study will enroll patients diagnosed with PD according to the MDS criteria, aged 18-80, with modified Hoehn-Yahr stages 1-2.5, and who have not previously used Entacapone. Participants will be assigned to two groups based on their prior treatment history: the LBE group (levodopa/benserazide/entacapone) or the LB group (levodopa/benserazide only), according to their actual clinical treatment plan. The study will observe patients over a 24-week period, evaluating changes in motor symptoms using the MDS-UPDRS Part III score as the primary endpoint. Secondary outcomes include assessments of daily living abilities, motor complications, quality of life (PDQ-39), cognitive function (MMSE), global impression (CGI), and safety profiles, including adverse event reporting. This study does not involve any interventional treatment changes; all therapeutic decisions remain at the discretion of the treating physicians. The findings are expected to provide real-world evidence regarding the potential benefits and safety of adding Entacapone to Madopar in the management of early PD.

Conditions

Parkinson Disease (PD)

Keywords

Parkinson Disease; Levodopa; Benserazide; Entacapone

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Week 24 in the MDS-UPDRS Part III (Motor Examination) score

  The MDS-UPDRS Part III (Motor Examination) assesses the motor function of patients with Parkinson's disease. The total score ranges from 0 to 132, with higher scores indicating greater motor impairment. The change from baseline to Week 24 will be analyzed to evaluate treatment efficacy.

  Baseline to Week 24

Secondary Outcomes (6)

• Change from baseline to Week 24 in the MDS-UPDRS Parts II and III total score

  Baseline to Week 24

• Change from baseline to Week 24 in the MDS-UPDRS Part II (Activities of Daily Living) score

  Baseline to Week 24

• Change from baseline to Week 24 in the MDS-UPDRS Part IV score

  Baseline to Week 24

• Change from baseline to Week 24 in the PDQ-39 summary index score

  Baseline to Week 24

• Change from baseline to Week 24 in the Clinical Global Impression (CGI) score

  Baseline to Week 24

Study Arms (2)

Madopar Group

Participants in this group will receive Madopar (levodopa/benserazide) as part of their routine clinical treatment. Treatment decisions, including dosage and frequency, will be made by the treating physician according to the patient's clinical condition. The typical treatment for levodopa-naïve patients is Madopar 100/25 mg taken three times daily (TID) for 24 weeks. For patients already on levodopa therapy, the physician may continue the current Madopar dosage as part of routine care. This is an observational study, and no specific interventions are assigned by the study.

Entacapone + Madopar Group

Participants in this group will receive Entacapone (200 mg) in combination with Madopar (levodopa/benserazide, typically 100/25 mg) as part of their routine clinical treatment. The typical regimen is Entacapone 200 mg administered three times daily (TID), or at a frequency matching the patient's levodopa dosing schedule, as determined by the treating physician based on the patient's clinical condition. The study is observational in nature, and no specific intervention is assigned by the study team. All treatment decisions, including drug type, dosage, and frequency, are made by the treating physician as part of routine care.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll adult patients diagnosed with Parkinson's disease according to MDS criteria, aged between 18 and 80 years, and in the early stages of the disease (modified Hoehn-Yahr stage 1-2.5). Participants must have a Mini-Mental State Examination (MMSE) score ≥26 and a Beck Depression Inventory (BDI) score \<15. Eligible patients will include those who are either levodopa-naïve or have been on a stable dose of levodopa (300-600 mg/day) for at least one month. All participants must voluntarily agree to join the study, provide informed consent, and be able to comply with the study protocol.

You may qualify if:

• Age between 18 and 80 years;
• Diagnosed with Parkinson's Disease based on the MDS criteria, confirmed by a movement disorder neurologist;
• Modified Hoehn and Yahr stage between 1 and 2.5;
• No prior use of entacapone;
• MMSE score ≥ 26;
• BDI (Beck Depression Inventory) score \< 15;
• Either:
• Has never used levodopa before, or
• Has been on a stable dose of levodopa (300-600 mg/day) for at least 1 month prior to enrollment;
• Stable doses of amantadine, anticholinergics, dopamine agonists, selegiline, or rasagiline are allowed if maintained for at least 30 days prior to and during the study;
• Willing and able to give informed consent and comply with study procedures, with caregiver support if needed.

You may not qualify if:

• Previous use of entacapone or tolcapone for more than 30 days, or within 4 weeks before baseline;
• Use of dopamine agonists within 4 weeks before baseline;
• BDI score ≥ 15;
• MMSE score \< 26;
• Unstable levodopa dosage;
• History of dyskinesia;
• Diagnosis of atypical or secondary parkinsonism, or history of PD-related neurosurgery;
• Clinically significant medical conditions within the past 5 years that could interfere with study participation;
• Use of medications known to induce parkinsonism;
• Participation in other investigational drug trials within 30 days before baseline.

Sponsors & Collaborators

• Yousheng Xiao: lead
• Jiangbin Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Guangxi International Zhuang Medicine Hospital: collaborator
• Ethnic Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guanxi, 530021, China

RECRUITING

Related Publications (7)

• Stocchi F, Rascol O, Kieburtz K, Poewe W, Jankovic J, Tolosa E, Barone P, Lang AE, Olanow CW. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann Neurol. 2010 Jul;68(1):18-27. doi: 10.1002/ana.22060.

  PMID: 20582993 BACKGROUND

• Fung VS, Herawati L, Wan Y; Movement Disorder Society of Australia Clinical Research and Trials Group; QUEST-AP Study Group. Quality of life in early Parkinson's disease treated with levodopa/carbidopa/entacapone. Mov Disord. 2009 Jan 15;24(1):25-31. doi: 10.1002/mds.21878.

  PMID: 18846551 BACKGROUND

• Lew MF, Somogyi M, McCague K, Welsh M; Lce QoL Study Group. Immediate versus delayed switch from levodopa/carbidopa to levodopa/carbidopa/entacapone: effects on motor function and quality of life in patients with Parkinson's disease with end-of-dose wearing off. Int J Neurosci. 2011 Nov;121(11):605-13. doi: 10.3109/00207454.2011.598982. Epub 2011 Aug 16.

  PMID: 21843110 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

• Liao X, Wu N, Liu D, Shuai B, Li S, Li K. Levodopa/carbidopa/entacapone for the treatment of early Parkinson's disease: a meta-analysis. Neurol Sci. 2020 Aug;41(8):2045-2054. doi: 10.1007/s10072-020-04303-x. Epub 2020 Mar 11.

  PMID: 32162166 BACKGROUND

• Kuoppamaki M, Leinonen M, Poewe W. Efficacy and safety of entacapone in levodopa/carbidopa versus levodopa/benserazide treated Parkinson's disease patients with wearing-off. J Neural Transm (Vienna). 2015 Dec;122(12):1709-14. doi: 10.1007/s00702-015-1449-6. Epub 2015 Sep 7.

  PMID: 26347184 BACKGROUND

Related Links

• Entacapone combined with levodopa/benserazide or levodopa/carbidopa in early Parkinson's disease.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yousheng Xiao, PhD

CONTACT

+86-15177196935; xys135@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief Physician, Department of Neurology, The First Affiliated Hospital of Guangxi Medical University

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 15, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (1)