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

University Hospital of Ferrara

Status: Completed

Conditions: Parkinson Disease; Effect of Drug

Treatments: Drug: Duodopa; Drug: Opicapone 50 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06432309

480/2022/Oss/AOUFe

Details and patient eligibility

About

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).

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy

Other group

Description:

Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.

Treatment:

Drug: Duodopa

add-OPC: Duodopa plus OPC therapy

Active Comparator group

Description:

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)

Treatment:

Drug: Duodopa

Drug: Opicapone 50 mg