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

Not Applicable

Completed

• Conditions: Effect of Drug; Parkinson Disease
• Interventions: Drug: Opicapone 50 mg; Drug: Duodopa

• Registration Number: NCT06432309
• Lead Sponsor: University Hospital of Ferrara

Brief 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).

Detailed 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 Timeline

• Study Start: 2022-07-01
• Status Verified: 2022-10
• Primary Completion: 2023-12-31
• Study Completion: 2024-04-25
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-05-29
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. LCIG implantation not longer than 30 months before the study enrollment,
2. Presence of nocturnal akinesia (assessed by medical history and through item 2.9 of MDS-UPDRS part II (> 2), or/and
3. Persistence of morning or afternoon akinesia (assessed by item 4.3 in MDS UPDRS -IV( >2 ).

Exclusion Criteria

1. Hoehn & Yahr (H&Y) >4,
2. Cognitive decline (MOCA< 17),
3. more than 30 months after LCIG positioning,
4. not compliant with treatment and follow-up visits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
add-OPC: Duodopa plus OPC therapy	Opicapone 50 mg	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)
add-OPC: Duodopa plus OPC therapy	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)
nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy	Duodopa	Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.

Primary Outcome Measures

Name	Time	Method
Evaluation of motor fluctuations changes	12 months	Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up.
Evaluation of dyskinesia changes	12 months	Changes in UDysRS from the initial assessment to 12 months follow-up.

Secondary Outcome Measures

Name	Time	Method
Changes in non-motor aspects of patients' daily living experiences	12 months	Changes of MDS-UPDRS I score from the initial assessment to 12 months follow-up.
Neurophysiological outcome	12 months	Changes of sural amplitude potential through electroneurography from the initial assessment to 12 months follow-up.
Changes in motor aspects of patients' daily living experiences	12 months	Changes of of MDS-UPDRS II score from the initial assessment to 12 months follow-up.
Changes in non-motor symptoms in Parkinson's disease-cognition	12 months	Changes of MOCA score from the initial assessment to 12 months follow-up.

Trial Locations

Locations (1)

University Hospital of Ferrara - Arcispedale Sant'Anna; 🇮🇹 Ferrara, Emilia Romagna, Italy