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This is a, open-label, single-arm 8-week investigation of levodopa/carbidopa/entacapone in the treatment of early Parkinson's disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levodopa/carbidopa/entacapone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 8 |
| Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-feng Liu, MD,PhD | Contact | +8613606210609 | liuchunfeng@suda.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chun-Feng Liu, MD,PhD | Second Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Soochow University | Recruiting | Shanghai | Shanghai Municipality | 2I5004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30178019 | Background | Homayoun H. Parkinson Disease. Ann Intern Med. 2018 Sep 4;169(5):ITC33-ITC48. doi: 10.7326/AITC201809040. | |
| 11391738 | Background | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| C481098 | Stalevo |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
|
The PDQ-39 instrument is used to assess quality of life in individuals with PD. A lower score indicates better quality of life. |
| 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. | Baseline, Week 8 |
| 28813703 | Background | 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. |
| 21437987 | Background | 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. |
| 24253234 | 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. |
| 19058133 | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |