Evidence map›Paper›PMID 29039979›Full record

Trial reportJournal of child and adolescent psychopharmacology2018

Single-Dose Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate Formulation, in Healthy Adults and in Adolescents and Children with Attention-Deficit/Hyperactivity Disorder.

Ann Childress, Shailly Mehrotra, Jogarao Gobburu, Angus McLean, Norberto J DeSousa, Bev Incledon

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of child and adolescent psychopharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 12% 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  10. New Formulations of Stimulants: An Update for Clinicians.Journal of child and adolescent psychopharmacology · 2019
    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

6 authors at 1 institution in 1 country.

Ann Childress1 The Center for Psychiatry and Behavioral Medicine , Las Vegas, Nevada.
Shailly Mehrotra2 Center for Translational Medicine, School of Pharmacy, University of Maryland , Baltimore, Maryland.
Jogarao Gobburu2 Center for Translational Medicine, School of Pharmacy, University of Maryland , Baltimore, Maryland.
Angus McLean3 Ironshore Pharmaceuticals and Development, Inc. , Grand Cayman, Cayman Islands.
Norberto J DeSousa3 Ironshore Pharmaceuticals and Development, Inc. , Grand Cayman, Cayman Islands.
Bev Incledon3 Ironshore Pharmaceuticals and Development, Inc. , Grand Cayman, Cayman Islands.
University of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveCurrent extended-release (ER) formulations of psychostimulants used for treatment of attention-deficit/hyperactivity disorder (ADHD) provide an extended duration of ADHD symptom control; however, the onset of efficacy can be protracted and variable, leaving the early morning untreated. The primary objective was to characterize the single-dose pharmacokinetics and tolerability of HLD200, an evening-dosed, delayed-release (DR) and ER formulation of methylphenidate (MPH), in healthy adults and in adolescents and children with ADHD.

methodsThe pharmacokinetics and tolerability of a single, oral evening dose of HLD200 (54 mg) were evaluated in two single-center open-label studies: the first in healthy adults (n = 12) and the second in adolescents (n = 18) and children (n = 11) with ADHD. Primary pharmacokinetic endpoints were the rate and extent of MPH absorption (C

resultsHLD200 produced a pharmacokinetic profile characterized by an 8- to 10-hour delay in MPH release, followed by a period of extended controlled release, resulting in an ascending absorption profile that coincided with the early morning and afternoon. Mean values (coefficient of variation [CV]%) of weight-adjusted pharmacokinetic parameters were similar in adults and in adolescents and children with ADHD: C

conclusionsEvening-dosed HLD200 produces the intended DR and ER pharmacokinetic profile that provides a consistent predictable delay in initial MPH release until the early morning, followed by extended release across the day. The body weight-adjusted pharmacokinetics of HLD200 were similar between adults and adolescents and children with ADHD.

Indexed as

Administration, OralAdolescentAdultAge FactorsArea Under CurveAttention Deficit Disorder with HyperactivityCase-Control StudiesCentral Nervous System StimulantsChildCross-Over StudiesDelayed-Action PreparationsFemaleHumansMaleMethylphenidateMiddle AgedCentral Nervous System StimulantsDelayed-Action PreparationsMethylphenidateattention-deficit/hyperactivity disorderdelayed-releaseextended-releasemethylphenidatepharmacokinetics

Identifiers

PMID29039979
PMCPMC5771548
OpenAlexW2766293542

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.