Evidence map›Paper›PMID 36054562›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2022

Effect of Opicapone on Levodopa Pharmacokinetics in Patients with Fluctuating Parkinson's Disease.

Joaquim J Ferreira, Werner Poewe, Olivier Rascol, Fabrizio Stocchi, Angelo Antonini, Joana Moreira, Bruno Guimarães, José-Francisco Rocha, Patrício Soares-da-Silva

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
3.1field-weighted citation impact, top 7% of its field
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

22 citing papers in PubMed, 34 citations in OpenAlex.

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  17. Sublingual apomorphine in the treatment of Parkinson's disease.Journal of neural transmission (Vienna, Austria : 1996) · 2024
    Review
  18. Review
  19. Objective assessment of the effects of opicapone in Parkinson's disease through kinematic analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
  20. Review
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

9 authors at 6 institutions in 4 countries.

Joaquim J FerreiraLaboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.ORCID 0000-0003-3950-5113
Werner PoeweDepartment of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Olivier RascolDepartment of Neurosciences and Clinical Pharmacology, University of Toulouse, Toulouse, France.ORCID 0000-0002-1410-6397
Fabrizio StocchiDepartment of Neurology, University San Raffaele and IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) San Raffaele Pisana, Rome, Italy.
Angelo AntoniniParkinson and Movement Disorders Unit, Study Center for Neurodegeneration, Department of Neurosciences University of Padova, Padova, Italy.ORCID 0000-0003-1040-2807
Joana MoreiraBIAL-Portela & Ca S.A, Research & Development Department, Coronado, Portugal.
Bruno GuimarãesBIAL-Portela & Ca S.A, Research & Development Department, Coronado, Portugal.
José-Francisco RochaBIAL-Portela & Ca S.A, Research & Development Department, Coronado, Portugal.ORCID 0000-0003-2611-4850
Patrício Soares-da-SilvaBIAL-Portela & Ca S.A, Research & Development Department, Coronado, Portugal.
Bial (Portugal) · PTInnsbruck Medical University · ATIstituti di Ricovero e Cura a Carattere Scientifico · ITUniversité Fédérale de Toulouse Midi-Pyrénées · FRUniversity of Lisbon · PTUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInhibiting catechol-O-methyltransferase extends the plasma half-life of levodopa, potentially allowing physicians to optimize the levodopa regimen in patients with Parkinson's disease (PD) experiencing motor fluctuations.

objectivesTo evaluate the effects of once-daily opicapone on levodopa plasma pharmacokinetics and motor response when added to two different levodopa dosing regimens.

methodsA total of 24 patients with PD and motor fluctuations were enrolled in an exploratory, open-label, modified cross-over trial. Participants first received levodopa/carbidopa 500/125 mg (five intakes) for 2 weeks and were then randomly assigned (1:1) to levodopa/carbidopa 400/100 mg given over either four or five daily intakes plus opicapone 50 mg for an additional 2 weeks. Levodopa 12-hour pharmacokinetics was the primary outcome (ie, excluding the effect of last/evening levodopa/carbidopa intake), with motor complications evaluated as secondary outcomes.

resultsOver 12-hour pharmacokinetics and compared with five-intake levodopa/carbidopa 500/125 mg without opicapone, maximal levodopa concentrations were similar or nonsignificantly higher on both levodopa/carbidopa 400/100 mg regimens plus opicapone. Despite a 100 mg lower total levodopa/carbidopa daily dose, adding opicapone 50 mg at least doubled the levodopa plasma half-life and minimal concentrations, with a significant ≈30% increase in total exposure. The levodopa fluctuation index was only significantly lower for the five intakes plus opicapone regimen (difference of -71.8%; P < 0.0001). Modifications to levodopa pharmacokinetics were associated with decreased off time and increased on time.

conclusionsCombining opicapone 50 mg with a 100 mg lower daily dose of levodopa provides higher levodopa bioavailability with avoidance of trough levels. Despite the lower levodopa dose, modifying the levodopa pharmacokinetic profile with opicapone was associated with decreased off time and increased on time. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Indexed as

LevodopaParkinson DiseaseAntiparkinson AgentsCarbidopaCatechol O-MethyltransferaseCatechol O-Methyltransferase InhibitorsCross-Over StudiesHumansOxadiazolesAntiparkinson AgentsCarbidopaCatechol O-MethyltransferaseCatechol O-Methyltransferase InhibitorsLevodopaopicaponeOxadiazolesCOMT inhibitorslevodopamotor responseopicaponepharmacokinetics

Identifiers

PMID36054562
OpenAlexW4293723298

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.