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Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease — OPAILEC  

Parkinson Disease Clinical Trial

Official title:
Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06432309
Study type Interventional
Source University Hospital of Ferrara
Contact
Status Completed
Phase N/A
Start date October 1, 2022
Completion date April 25, 2024
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