Parkinson Disease (PD)NCT06928519
Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease: An Observational, Multicenter, Case-Control Study
An observational study of Parkinson Disease (PD), run by Yousheng Xiao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease (PD)
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guanxi, 530021
Yousheng Xiao Yousheng Xiao, MD, +86 15177196935, xys135@126.com
Yousheng Xiao, MD
About this study
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.
Read the detailed description
This is an observational, multicenter, case-control study designed to evaluate the efficacy and safety of Entacapone combined with Madopar (Levodopa/Benserazide, LB) in the treatment of early-stage Parkinson's disease (PD) in Chinese patients. The study is conducted across multiple centers in China and includes patients diagnosed with PD according to the MDS criteria, aged 18-80 years, with a modified Hoehn-Yahr stage of 1-2.5. Participants will be divided into two groups based on their actual clinical treatment: (1) the LBE group (Levodopa/Benserazide/Entacapone) and (2) the LB group (Levodopa/Benserazide only). The study does not involve any randomization, blinding, or intervention allocation; instead, it reflects real-world clinical practice, where all treatment decisions are made solely by the attending physician.
The study will observe patients over a 24-week period to compare the effectiveness of the two treatment strategies in improving motor symptoms, daily living activities, and quality of life, as well as the incidence of adverse events. The primary outcome measure is the change in MDS-UPDRS Part III (motor examination) score from baseline to Week 24. Secondary outcomes include changes in MDS-UPDRS Part II (activities of daily living), Part IV (motor complications), total MDS-UPDRS II+III scores, PDQ-39 quality of life scores, Clinical Global Impression (CGI) scores, MMSE cognitive scores, and modified Hoehn-Yahr staging. Safety assessments include adverse events, serious adverse events, vital signs, laboratory tests, and ECG findings.
All treatments, including medication selection, dosage, and adjustment, will follow the treating physician's routine clinical judgment, and no intervention or modification by the study team will occur. Concomitant medications such as amantadine, anticholinergics, dopamine agonists, and MAO-B inhibitors (e.g., selegiline, rasagiline) are allowed if their doses are stable for at least 30 days before enrollment and remain unchanged throughout the study period.
The estimated sample size is 216 participants, with approximately 108 in each group, allowing for a 10% dropout rate. The study is expected to start in June 2025 and complete by April 2027, with final data analysis by June 2027. The results of this study aim to provide real-world evidence regarding the potential benefits and safety of Entacapone combined with Madopar in the early-stage PD population in China.
- Conditions
- Parkinson Disease (PD)
- Keywords
- Parkinson Disease, Levodopa, Benserazide, Entacapone
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 24
Secondary outcomes (6)
Change from baseline to Week 24 in the MDS-UPDRS Parts II and III total score
he MDS-UPDRS Part II assesses activities of daily living (maximum score: 52) and Part III assesses motor function (maximum score: 132). The combined total score (range: 0-184) reflects overall functional impairment, with higher scores indicating greater disability.
Measured: Baseline to Week 24
Change from baseline to Week 24 in the MDS-UPDRS Part II (Activities of Daily Living) score
The MDS-UPDRS Part II evaluates the impact of Parkinson's disease on activities of daily living (ADL), such as speech, handwriting, dressing, and walking. The total score ranges from 0 to 52, with higher scores indicating greater disability. The score change from baseline to Week 24 will be analyzed to assess treatment effectiveness on daily functioning.
Measured: Baseline to Week 24
Change from baseline to Week 24 in the MDS-UPDRS Part IV score
The MDS-UPDRS Part IV evaluates motor complications including dyskinesia and wearing-off phenomena. Changes in the score from baseline to Week 24 will be analyzed to assess treatment-related motor complications.
Measured: Baseline to Week 24
Change from baseline to Week 24 in the PDQ-39 summary index score
The Parkinson's Disease Questionnaire-39 (PDQ-39) assesses health-related quality of life across 8 domains. The summary index score reflects the overall impact of Parkinson's disease on quality of life, with higher scores indicating worse outcomes.
Measured: Baseline to Week 24
Change from baseline to Week 24 in the Clinical Global Impression (CGI) score
The Clinical Global Impression (CGI) scale is used by both investigators and participants to rate overall disease severity and clinical improvement. The score change from baseline to Week 24 will be used to assess perceived treatment effectiveness.
Measured: Baseline to Week 24
Change in modified Hoehn-Yahr stage from baseline to Week 24
The modified Hoehn-Yahr staging scale evaluates the severity and progression of Parkinson's disease, with higher stages indicating more advanced disease. Stage change from baseline to Week 24 will be used to assess disease progression or stability.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start5 Jun 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yousheng Xiao
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi International Zhuang Medicine Hospital, Ethnic Hospital of Guangxi Zhuang Autonomous Region, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor-investigator, Yousheng Xiao, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928519
- Sponsor's protocol ID
- EMPD-001
- Status last verified
- Jun 2025
- First submitted
- 22 Mar 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) is currently under review and will depend on ethical approvals, data use agreements, and institutional policy.
Publications
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.
PubMed 20582993Fung 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.
PubMed 18846551Lew 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.
PubMed 21843110Tolosa 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.
PubMed 24253234Hauser 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.
PubMed 19058133Liao 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.
PubMed 32162166Kuoppamaki 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.
PubMed 26347184
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease: An Observational, Multicenter, Case-Control Study
- ClinicalTrials.gov ID
- NCT06928519
- Acronym / sponsor ID
- EMPD-001
- Conditions
- Parkinson Disease (PD)
- Keywords
- Parkinson Disease, Levodopa, Benserazide, Entacapone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Yousheng XiaoUniversity, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi International Zhuang Medicine Hospital, Ethnic Hospital of Guangxi Zhuang Autonomous Region, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an observational, multicenter, case-control study designed to evaluate the efficacy and safety of Entacapone combined with Madopar (Levodopa/Benserazide, LB) in the treatment of early-stage Parkinson's disease (PD) in Chinese patients. The study is conducted across multiple centers in China and includes patients diagnosed with PD according to the MDS criteria, aged 18-80 years, with a modified Hoehn-Yahr stage of 1-2.5. Participants will be divided into two groups based on their actual clinical treatment: (1) the LBE group (Levodopa/Benserazide/Entacapone) and (2) the LB group (Levodopa/Benserazide only). The study does not involve any randomization, blinding, or intervention allocation; instead, it reflects real-world clinical practice, where all treatment decisions are made solely by the attending physician.
The study will observe patients over a 24-week period to compare the effectiveness of the two treatment strategies in improving motor symptoms, daily living activities, and quality of life, as well as the incidence of adverse events. The primary outcome measure is the change in MDS-UPDRS Part III (motor examination) score from baseline to Week 24. Secondary outcomes include changes in MDS-UPDRS Part II (activities of daily living), Part IV (motor complications), total MDS-UPDRS II+III scores, PDQ-39 quality of life scores, Clinical Global Impression (CGI) scores, MMSE cognitive scores, and modified Hoehn-Yahr staging. Safety assessments include adverse events, serious adverse events, vital signs, laboratory tests, and ECG findings.
All treatments, including medication selection, dosage, and adjustment, will follow the treating physician's routine clinical judgment, and no intervention or modification by the study team will occur. Concomitant medications such as amantadine, anticholinergics, dopamine agonists, and MAO-B inhibitors (e.g., selegiline, rasagiline) are allowed if their doses are stable for at least 30 days before enrollment and remain unchanged throughout the study period.
The estimated sample size is 216 participants, with approximately 108 in each group, allowing for a 10% dropout rate. The study is expected to start in June 2025 and complete by April 2027, with final data analysis by June 2027. The results of this study aim to provide real-world evidence regarding the potential benefits and safety of Entacapone combined with Madopar in the early-stage PD population in China.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline to Week 24 in the MDS-UPDRS Part III (Motor Examination) score
Time frame: Baseline to Week 24
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.
6 secondary outcomes
Change from baseline to Week 24 in the MDS-UPDRS Parts II and III total score
Time frame: Baseline to Week 24
Change from baseline to Week 24 in the MDS-UPDRS Part II (Activities of Daily Living) score
Time frame: Baseline to Week 24
Change from baseline to Week 24 in the MDS-UPDRS Part IV score
Time frame: Baseline to Week 24
Change from baseline to Week 24 in the PDQ-39 summary index score
Time frame: Baseline to Week 24
Change from baseline to Week 24 in the Clinical Global Impression (CGI) score
Time frame: Baseline to Week 24
Change in modified Hoehn-Yahr stage from baseline to Week 24
Time frame: Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Results publication: PubMed 20582993Stocchi 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.
- Results publication: PubMed 18846551Fung 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.
- Results publication: PubMed 21843110Lew 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.
- Results publication: PubMed 24253234Tolosa 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.
- Results publication: PubMed 19058133Hauser 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.
- Results publication: PubMed 32162166Liao 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.
- Results publication: PubMed 26347184Kuoppamaki 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.
- Entacapone combined with levodopa/benserazide or levodopa/carbidopa in early Parkinson's disease.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) is currently under review and will depend on ethical approvals, data use agreements, and institutional policy.
Related trials for Parkinson Disease (PD)
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease (PD), run by Yousheng Xiao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yousheng Xiao, PhD (+86-15177196935, xys135@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Week 24 in the MDS-UPDRS Part III (Motor Examination) score (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06928519, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.