Evidence map›Paper›PMID 27763682›Full record

Trial reportBritish journal of clinical pharmacology2017

Effect of opicapone multiple-dose regimens on levodopa pharmacokinetics.

José-Francisco Rocha, Éric Sicard, Nicolas Fauchoux, Amílcar Falcão, Ana Santos, Ana I Loureiro, Roberto Pinto, Maria João Bonifácio, Teresa Nunes, Luís Almeida and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.1field-weighted citation impact, top 20% 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

8 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Effect of opicapone multiple-dose regimens on levodopa pharmacokinetics.British journal of clinical pharmacology · 2017
    Trial
  3. 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
  4. Review
  5. Article
  6. Review
  7. Article
  8. 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

11 authors at 5 institutions in 3 countries.

José-Francisco RochaDept. Research & Development, BIAL - Portela & Cª - S.A., 4745-457, S. Mamede do Coronado, Portugal.
Éric SicardAlgorithme Pharma Inc., Quebec, Canada.
Nicolas FauchouxBiotrial, Rennes, France.
Amílcar FalcãoFaculty of Pharmacy, University of Coimbra, Coimbra, Portugal.
Ana SantosDept. Research & Development, BIAL - Portela & Cª - S.A., 4745-457, S. Mamede do Coronado, Portugal.
Ana I LoureiroDept. Research & Development, BIAL - Portela & Cª - S.A., 4745-457, S. Mamede do Coronado, Portugal.
Roberto PintoDept. Research & Development, BIAL - Portela & Cª - S.A., 4745-457, S. Mamede do Coronado, Portugal.
Maria João BonifácioDept. Research & Development, BIAL - Portela & Cª - S.A., 4745-457, S. Mamede do Coronado, Portugal.
Teresa NunesDept. Research & Development, BIAL - Portela & Cª - S.A., 4745-457, S. Mamede do Coronado, Portugal.
Luís AlmeidaDept. Pharmacology & Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal.
Patrício Soares-da-SilvaDept. Research & Development, BIAL - Portela & Cª - S.A., 4745-457, S. Mamede do Coronado, Portugal.
Bial (Portugal) · PTBioPhage Pharma (Canada) · CAStructure Fédérative de Recherche en Biologie et Santé de Rennes · FRUniversidade do Porto · PTUniversity of Coimbra · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the levodopa/carbidopa (LC) and levodopa/benserazide (LB) pharmacokinetic profiles following repeated doses of opicapone (OPC) administered apart from levodopa.

methodsTwo randomized, double blind, sex-balanced, placebo-controlled studies in four groups of 12 or 18 healthy subjects each. In each group, enrolled subjects received a once-daily morning (5, 15 and 30 mg) or evening (5, 15 and 50 mg) administration of OPC or placebo for up to 28 days. On the morning of Day 11, 12 h after the OPC or placebo evening dose, or the morning of Day 21, 1 h after the OPC or placebo dose, a single dose of immediate-release 100/25 mg LC was administered. Similarly, on Day 18 morning, 12 h after the OPC or placebo evening dose, or Day 28 morning, 1 h after the OPC or placebo dose, a single dose of immediate-release 100/25 mg LB was administered.

resultsAll OPC treatments, in relation to the placebo group, presented a higher extent of exposure (AUC) to levodopa following either LC or LB doses. A relevant but not dose-dependent increase in the levodopa AUC occurred with all OPC dose groups in relation to placebo. All active treatments significantly inhibited both peak (E

conclusionOpicapone, as once-daily oral evening regimen and/or 1 h apart from levodopa therapy, increases the bioavailability of levodopa associated with its pronounced, long-lasting and sustained catechol-O-methyltransferase inhibition. The tolerability profile was favourable and similar between OPC and placebo.

Indexed as

AdultAntiparkinson AgentsBenserazideBiological AvailabilityCarbidopaCatechol O-Methyltransferase InhibitorsDose-Response Relationship, DrugDouble-Blind MethodDrug CombinationsFemaleHumansLevodopaMaleMiddle AgedOxadiazolesAntiparkinson AgentsBenserazidebenserazide, levodopa drug combinationCarbidopaCatechol O-Methyltransferase InhibitorsDrug CombinationsLevodopaopicaponeOxadiazolesbenserazidecarbidopacatechol-O-methyltransferase inhibitorslevodopaopicaponepharmacokinetics

Identifiers

PMID27763682
PMCPMC5306497
OpenAlexW2541999838

What OpenQuestion holds

Textmetadata
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.