Evidence map›Paper›PMID 30739576›Full record

Trial reportJournal of child neurology2019

Adjunctive Perampanel Oral Suspension in Pediatric Patients From ≥2 to <12 Years of Age With Epilepsy: Pharmacokinetics, Safety, Tolerability, and Efficacy.

J Ben Renfroe, Mark Mintz, Ronald Davis, Jose Ferreira, Sharon Dispoto, Jim Ferry, Yuko Umetsu, Bhaskar Rege, Oneeb Majid, Ziad Hussein and 1 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of child neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
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  8. Article
  9. Kainate Receptor Antagonists: Recent Advances and Therapeutic Perspective.International journal of molecular sciences · 2023
    Review
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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.

J Ben Renfroe1 Child Neurology Center of Northwest Florida, Gulf Breeze, FL, USA.
Mark Mintz2 The Center for Neurological and Neurodevelopmental Health (CNNH) and the Clinical Research Center of New Jersey (CRCNJ), Voorhees, NJ, USA.
Ronald Davis3 Pediatric Neurology, P.A., and Epilepsy Center of Central Florida, Orlando, FL, USA.
Jose Ferreira4 Department of Pediatrics, University of South Florida, School of Medicine, Tampa, FL, USA.
Sharon Dispoto7 Eisai Neurology Business Group, Eisai Inc., Woodcliff Lake, NJ, USA.
Jim Ferry8 Eisai Clinical Pharmacology, Eisai Inc., Woodcliff Lake, NJ, USA.
Yuko Umetsu9 Eisai Co., Ltd., Tokyo, Japan.
Bhaskar Rege10 Formerly: Eisai Clinical Pharmacology, Eisai Inc., Woodcliff Lake, NJ, USA.
Oneeb Majid11 Eisai Clinical Pharmacology, Eisai Ltd., European Knowledge Centre, Hatfield, Hertfordshire, United Kingdom.
Ziad Hussein11 Eisai Clinical Pharmacology, Eisai Ltd., European Knowledge Centre, Hatfield, Hertfordshire, United Kingdom.
Antonio Laurenza12 Formerly: Eisai Neurology Business Group, Eisai Inc., Woodcliff Lake, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Study 232, an open-label pilot study with an extension phase, evaluated the pharmacokinetics and preliminary safety/tolerability and efficacy of adjunctive perampanel oral suspension (≤0.18 mg/kg/d) in epilepsy patients aged ≥2 to <12 years. Patients were grouped into cohorts 1 (aged ≥7 to <12 years) and 2 (aged ≥2 to <7 years). The Core Study included pretreatment (≤2 weeks) and treatment phases (7-week titration; 4-week maintenance; 4-week follow-up [for those not entering the extension]). The extension phase consisted of 41-week maintenance and 4-week follow-up periods. Pharmacokinetic data were pooled with adolescent pharmacokinetic data from phase II/III studies. Population pharmacokinetic analysis showed that perampanel pharmacokinetics was independent of age, weight, or liver function, suggesting age- or weight-based dosing is not required and that the same dose can be given to adults and children to achieve exposures shown to be efficacious. Perampanel was well tolerated and efficacious for ≤52 weeks.

Indexed as

Administration, OralAdolescentAnticonvulsantsChildChild, PreschoolDrug Therapy, CombinationEpilepsyHumansNitrilesPilot ProjectsPyridonesSeizuresTreatment OutcomeAnticonvulsantsNitrilesperampanelPyridonesantiepileptic drugsefficacyepilepsypediatricseizures

Identifiers

PMID30739576
PMCPMC6444512

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.