Parkinson DiseasePhase 4NCT06236230
Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease
A Phase 4 study testing levodopa/carbidopa/entacapone in people with Parkinson Disease, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is a, open-label, single-arm 8-week investigation of levodopa/carbidopa/entacapone in the treatment of early Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- levodopa/carbidopa/entacapone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2023to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Soochow University
Shanghai, Shanghai Municipality, 2I5004
Chun-Feng Liu, MD,PhD, +8613606210609, liuchunfeng@suda.edu.cn
About this study
This is a, open-label, single-arm 8-week investigation of levodopa/carbidopa/entacapone in the treatment of early Parkinson's disease.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- levodopa/carbidopa/entacapone
- Keywords
- Parkinson Disease, levodopa/carbidopa/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.
levodopa/carbidopa/entacaponeDrug
Also called Stalevo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: levodopa/carbidopa/entacapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8
Secondary outcomes (3)
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 8
Incidence of dyskinesia and wearing off
Dyskinesia and wearing off are common motor complications. A motor complications patient questionnaire will be record.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start15 Nov 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Feng Liu, MD,PhD, Principal investigator, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236230
- Sponsor's protocol ID
- JD-LK2023062-IR01
- Status last verified
- Dec 2023
- First submitted
- 24 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Homayoun H. Parkinson Disease. Ann Intern Med. 2018 Sep 4;169(5):ITC33-ITC48. doi: 10.7326/AITC201809040.
PubMed 30178019Ahlskog 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.
PubMed 11391738Li 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.
PubMed 28813703Hauser 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.
PubMed 21437987Tolosa 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 19058133
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06236230
- Acronym / sponsor ID
- JD-LK2023062-IR01
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, levodopa/carbidopa/entacapone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Feb 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| levodopa/carbidopa/entacapone | Experimental | Drug: levodopa/carbidopa/entacaponelevodopa/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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levodopa/carbidopa/entacaponeAlso: StalevoOn 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. | Drug | levodopa/carbidopa/entacapone |
Primary outcome
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) III Score
Time frame: Baseline, Week 8
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.
3 secondary outcomes
Change From Baseline in UPDRS II Score
Time frame: Baseline, Week 8
Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Baseline, Week 8
Incidence of dyskinesia and wearing off
Time frame: Baseline, Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 30178019Homayoun H. Parkinson Disease. Ann Intern Med. 2018 Sep 4;169(5):ITC33-ITC48. doi: 10.7326/AITC201809040.
- Background: PubMed 11391738Ahlskog 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.
- Background: PubMed 28813703Li 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.
- Background: PubMed 21437987Hauser 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.
- Background: 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.
- Background: 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Chun-Feng Liu, MD,PhD principal investigator
Second Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levodopa/carbidopa/entacapone in people with Parkinson Disease, run by Second Affiliated Hospital of Soochow University 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-feng Liu, MD,PhD (+8613606210609, liuchunfeng@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) III Score (time frame: Baseline, Week 8). 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 NCT06236230, which also lists 6 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 1 Feb 2024.