An interventional study of Opicapone 50 mg and Duodopa in Parkinson Disease and Effect of Drug, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 22 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Hospital of Ferrara is the lead sponsor of 110 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.
Drug: Duodopa
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)
Drug: Opicapone 50 mg · Drug: Duodopa
Evaluate the addition of the COMT-I, Opicapone, to the Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.
Also known as: OPC
Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.
Also known as: Levodopa/carbidopa intestinal gel (LCIG)
Evaluation of motor fluctuations changes
Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up.
Time frame: 12 months
Evaluation of dyskinesia changes
Changes in UDysRS from the initial assessment to 12 months follow-up.
Time frame: 12 months
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.
Time frame: 12 months
Changes in motor aspects of patients' daily living experiences
Changes of of MDS-UPDRS II score from the initial assessment to 12 months follow-up.
Time frame: 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.
Time frame: 12 months
Neurophysiological outcome
Changes of sural amplitude potential through electroneurography from the initial assessment to 12 months follow-up.
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University Hospital of Ferrara