Evidence map›Paper›PMID 40662211›Full record

Trial reportMovement disorders clinical practice2025

Opicapone in Parkinson's Disease on Levodopa-Carbidopa Intestinal Gel Treatment: A Pilot, Randomized Study.

Fabiana Colucci, Andrea Gozzi, Pietro Antenucci, Ilaria Casetta, Lorenza Maistrello, Annibale Antonioni, Emanuela Maria Raho, Ginevra Tecilla, Jay Guido Capone, Mariachiara Sensi

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Movement disorders clinical practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Fabiana ColucciUniversità degli Studi di Ferrara, Ferrara, Italy.ORCID https://orcid.org/0000-0003-1945-8153
Andrea GozziUniversità degli Studi di Ferrara, Ferrara, Italy.ORCID https://orcid.org/0000-0002-5248-791X
Pietro AntenucciUniversità degli Studi di Ferrara, Ferrara, Italy.
Ilaria CasettaIRCCS San Camillo Hospital, Venice, Italy.
Lorenza MaistrelloIRCCS San Camillo Hospital, Venice, Italy.
Annibale AntonioniUniversità degli Studi di Ferrara, Ferrara, Italy.ORCID https://orcid.org/0000-0003-1555-6418
Emanuela Maria RahoDepartment of Neuroscience and Rehabilitation, Azienda Ospedaliero-Universitaria S. Anna, Ferrara, Italy.
Ginevra TecillaAPSS Ospedale S. Maria del Carmine, Rovereto, Italy.
Jay Guido CaponeDepartment of Neuroscience and Rehabilitation, Azienda Ospedaliero-Universitaria S. Anna, Ferrara, Italy.
Mariachiara SensiDepartment of Neuroscience and Rehabilitation, Azienda Ospedaliero-Universitaria S. Anna, Ferrara, Italy.ORCID https://orcid.org/0000-0002-6434-5433

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLevodopa-carbidopa intestinal gel infusion (LCIG) is an effective therapy for advanced Parkinson's disease (PD). Opicapone (OPC) is an enzyme inhibitor that enhances the bioavailability of levodopa in the brain.

objectivesThis study evaluates the effect of Opicapone addition in PD-LCIG patients, assessing its impact on motor fluctuations and dyskinesias. Secondly, the study analyses the impact of OPC on non-motor symptoms, LCIG dosage, and peripheral neuropathy.

methodsIn this pilot study, 22 PD patients on LCIG were randomized to receive OPC or not, based on persistent or reemergent fluctuations. The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Unified Dyskinesia Rating Scale (UDysRS), Montreal Cognitive Assessment (MoCA), electroneurography (ENG), LCIG doses, homocysteine, vitamin B12, and folic acid levels were measured at baseline (T0) and after 12 months (T1).

resultsEleven patients added OPC (addOPC group), while 11 maintained standard treatment (nOPC group). At baseline, both groups had similar disease duration and severity. At T1, the addOPC group showed significant: (i) improvement in motor fluctuations evaluated by the MDS-UPDRS part IV; (ii) reduction in dyskinesias (UDyRS); (iii) decrease in LCIG infusion rate; (iv) improvement in motor and non-motor symptoms (MDS-UPDRS parts I-III); (v) increase in Vitamin B12. No significant differences were observed in the ENG data, and no serious adverse events occurred. Four addOPC patients (36%) discontinued OPC after 15 ± 2 months, mainly due to hallucinations.

conclusionsOPC addition appeared well tolerated and beneficial in reducing motor fluctuations, dyskinesia, and LCIG dose. Randomized controlled trials are needed to confirm these findings.

Indexed as

Antiparkinson AgentsCarbidopaLevodopaOxadiazolesParkinson DiseaseAgedDrug CombinationsDrug Therapy, CombinationFemaleGelsHumansMaleMiddle AgedPilot ProjectsSeverity of Illness IndexTreatment OutcomeAntiparkinson AgentsCarbidopacarbidopa, levodopa drug combinationDrug CombinationsGelsLevodopaopicaponeOxadiazolesdyskinesiashomocysteinemialevodopa/carbidopa intestinal gelOpicaponeParkinson's disease

Identifiers

PMID40662211
PMCPMC12625100

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.