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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-04-25

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Parkinson Disease Effect of Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomised blinded End-point study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

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

Group Type OTHER

Duodopa

Intervention Type DRUG

Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.

add-OPC: Duodopa plus OPC therapy

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)

Group Type ACTIVE_COMPARATOR

Opicapone 50 mg

Intervention Type DRUG

Evaluate the addition of the COMT-I, Opicapone, to the Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.

Duodopa

Intervention Type DRUG

Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.

Interventions

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Opicapone 50 mg

Evaluate the addition of the COMT-I, Opicapone, to the Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.

Intervention Type DRUG

Duodopa

Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.

Intervention Type DRUG

Other Intervention Names

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OPC Levodopa/carbidopa intestinal gel (LCIG)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No