Evidence map›Paper›PMID 32776159›Full record

Trial reportPaediatric drugs2020

A Pharmacokinetic Study of Methylphenidate Hydrochloride Multilayer Extended-Release Capsules (Aptensio XR

Akwete L Adjei, Inder Chaudhary, Scott H Kollins, Americo Padilla

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Paediatric drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02470234 (A Pharmacokinetic Study of Aptensio XR®), which is not on this map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 33% 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.

NCT02470234 phase4completednot on this map

A Pharmacokinetic Study of Aptensio XR® (Methylphenidate Hydrochloride (HCl) Extended-release) Capsules in Male or Female Pre-School Children 4 to Under 6 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD) in Fed Condition

TypeinterventionalSponsorRhodes Pharmaceuticals, L.P.Ran2016 to 2017Enrolled10ConditionsAttention-Deficit/Hyperactivity DisorderArmsMethylphenidate HCl ER Capsules, 10 mg, Methylphenidate HCl ER Capsules, 15 mg, Methylphenidate HCl ER Capsules, 20 mg
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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

4 authors at 3 institutions in 2 countries.

Akwete L AdjeiRhodes Pharmaceuticals L.P., 498 Washington St., Coventry, RI, 02816, USA. akwete.adjei@rhodespharma.com.ORCID http://orcid.org/0000-0001-5772-7866
Inder ChaudharyRhodes Pharmaceuticals L.P., 498 Washington St., Coventry, RI, 02816, USA.
Scott H KollinsDepartment of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.
Americo PadillaDepartment of Pediatric Psychiatry, Nicklaus Children's Hospital, Miami, FL, USA.
Duke University · USGeneral Hospital of Rhodes · GRMiami Children's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis was a single-dose, one-period, multicenter, pharmacokinetic (PK) study to evaluate the PK of methylphenidate (MPH) hydrochloride multilayer extended-release capsules (MPH-MLR) in preschool children aged 4 to < 6 years, previously diagnosed with attention-deficit/hyperactivity disorder (ADHD), and on a stable dose of MPH.

methodsPreschool-aged children (N = 10) received a single oral dose of MPH-MLR (10, 15, or 20 mg) sprinkled over applesauce; a dose equivalent to their pre-enrollment daily dose of MPH. Blood samples for the measurement of MPH concentrations were obtained pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose. No structural model was assumed in the derivation of PK values for analysis. Maximum plasma concentration (C

resultsMean dose-normalized C

conclusionThe PK of MPH-MLR in preschool children demonstrated the biphasic absorption profile described earlier in older children, and the PK profile in children with ADHD aged 4 to < 6 years was similar to the profile in those aged 6-11 years, apart from a lower V

trial registrationClinicaltrials.gov Identifier: NCT02470234.

Indexed as

AdultAttention Deficit Disorder with HyperactivityBody WeightCapsulesCentral Nervous System StimulantsChildChild, PreschoolDelayed-Action PreparationsFemaleHumansMaleMethylphenidateModels, BiologicalCapsulesCentral Nervous System StimulantsDelayed-Action PreparationsMethylphenidate

Identifiers

PMID32776159
PMCPMC7529626
OpenAlexW3048844122

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.