Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease
NCT ID: NCT06236230
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2023-11-15
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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levodopa/carbidopa/entacapone
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.
levodopa/carbidopa/entacapone
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.
Interventions
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levodopa/carbidopa/entacapone
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
80 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Principal Investigators
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Chun-Feng Liu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital of Soochow University
Locations
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The Second Affiliated Hospital of Soochow University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Homayoun H. Parkinson Disease. Ann Intern Med. 2018 Sep 4;169(5):ITC33-ITC48. doi: 10.7326/AITC201809040.
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.
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.
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.
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.
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.
Other Identifiers
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JD-LK2023062-IR01
Identifier Type: -
Identifier Source: org_study_id
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