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Levodopa-Carbidopa intestinal gel (LCIG) is an effective therapy for complicated Parkinson's disease (PD). Few studies have explored the efficacy and safety of the potential combination of LCIG with catechol-O-methyltransferase (COMT) inhibitors, particularly Opicapone (OPC).
22 PD patients were randomized into LCIG monotherapy (n-OPC 11 patients) and LCIG+OPC (add-OPC 11 patients), further divided according to OPC adding time (E-OPC within one month and L-OPC after one month from LCIG implant).
Data on PD clinical aspects, Montreal Cognitive Assessment (MoCA), Unified Parkinson's Disease Rating Scale (UPDRS), Unified Dyskinesia Rating Scale (UDysRS), electroneurography (ENG), and pharmacological therapy (Levodopa Equivalent Dose-LEDD) were collected before LCIG implanted (T0) and in the following 12 (T1) months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy | Other | Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m. |
|
| add-OPC: Duodopa plus OPC therapy | Active Comparator | Levodopa carbidopa intestinal gel infusion (Diurnal infusion from 7 a.m to 11 p.m) plus Opicapone 50 mg 1 tablet at nighttime (11 p.m) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opicapone 50 mg | Drug | Evaluate the addition of the COMT-I, Opicapone, to the Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of motor fluctuations changes | Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up. | 12 months |
| Evaluation of dyskinesia changes | Changes in UDysRS from the initial assessment to 12 months follow-up. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in non-motor aspects of patients' daily living experiences | Changes of MDS-UPDRS I score from the initial assessment to 12 months follow-up. | 12 months |
| Changes in motor aspects of patients' daily living experiences |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariachiara Sensi, MD-Phd | Azienda Ospedaliero -Universitaria S. Anna Ferrara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Ferrara - Arcispedale Sant'Anna | Ferrara | Emilia-Romagna | 44122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35785401 | Background | Nyholm D, Jost WH. Levodopa-entacapone-carbidopa intestinal gel infusion in advanced Parkinson's disease: real-world experience and practical guidance. Ther Adv Neurol Disord. 2022 Jun 26;15:17562864221108018. doi: 10.1177/17562864221108018. eCollection 2022. | |
| 30264443 | Background | Fabbri M, Ferreira JJ, Lees A, Stocchi F, Poewe W, Tolosa E, Rascol O. Opicapone for the treatment of Parkinson's disease: A review of a new licensed medicine. Mov Disord. 2018 Oct;33(10):1528-1539. doi: 10.1002/mds.27475. Epub 2018 Sep 27. |
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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 |
|---|---|
| C549349 | opicapone |
| C009265 | carbidopa, levodopa drug combination |
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Prospective randomised blinded End-point study
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|
| Duodopa | Drug | Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations. |
|
|
Changes of of MDS-UPDRS II score from the initial assessment to 12 months follow-up.
| 12 months |
| Changes in non-motor symptoms in Parkinson's disease-cognition | Changes of MOCA score from the initial assessment to 12 months follow-up. | 12 months |
| Neurophysiological outcome | Changes of sural amplitude potential through electroneurography from the initial assessment to 12 months follow-up. | 12 months |
| 38287715 | Background | Ikenaka K, Kajiyama Y, Aguirre C, Choong CJ, Taniguchi S, Doi J, Wang N, Ajiki T, Ogawa K, Kakuda K, Kimura Y, Mochizuki H. Decreased hepatic enzymes reflect the decreased vitamin B6 levels in Parkinson's disease patients. Pharmacol Res Perspect. 2024 Feb;12(1):e1174. doi: 10.1002/prp2.1174. |
| 32597817 | Result | Leta V, van Wamelen DJ, Sauerbier A, Jones S, Parry M, Rizos A, Chaudhuri KR. Opicapone and Levodopa-Carbidopa Intestinal Gel Infusion: The Way Forward Towards Cost Savings for Healthcare Systems? J Parkinsons Dis. 2020;10(4):1535-1539. doi: 10.3233/JPD-202022. |
| 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 |