Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432309
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-07
Brief Title:
Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinsons Disease
Sponsor:
University Hospital of Ferrara
Organization:
University Hospital of Ferrara
Study Overview
Official Title:
Efficacy and Safety of Opicapone in Parkinsons Disease Add -on to Levodopa Carbidopa Intestinal Gel
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPAILEC
Brief Summary:
Levodopa-Carbidopa intestinal gel LCIG is an effective therapy for complicated Parkinsons 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
Detailed Description:
22 PD patients were randomized into LCIG monotherapy n-OPC 11 patients and LCIGOPC 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 Parkinsons 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
Data on PD clinical aspects Montreal Cognitive Assessment MoCA Unified Parkinsons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None