Evidence map›Paper›PMID 35588245›Full record

ArticleBritish journal of clinical pharmacology2022

The role of placebo response in the efficacy outcome assessment in viloxazine extended-release pivotal trials in paediatric subjects with attention-deficit/hyperactivity disorder.

Azmi Nasser, Roberto Gomeni, Zhao Wang, Joseph T Hull, Gregory D Busse, Zare Melyan, Maurizio Fava, Welton O'Neal, Jonathan Rubin

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 39% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. 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

9 authors at 3 institutions in 2 countries.

Azmi NasserSupernus Pharmaceuticals, Inc., Rockville, MD, USA.ORCID 0000-0003-0514-8410
Roberto GomeniPharmacometrica, Lieu-dit Longcol, La Fouillade, France.
Zhao WangSupernus Pharmaceuticals, Inc., Rockville, MD, USA.
Joseph T HullSupernus Pharmaceuticals, Inc., Rockville, MD, USA.
Gregory D BusseFormerly with Supernus Pharmaceuticals, Inc., Rockville, MD, USA.
Zare MelyanFormerly with Supernus Pharmaceuticals, Inc., Rockville, MD, USA.
Maurizio FavaDepartment of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
Welton O'NealSupernus Pharmaceuticals, Inc., Rockville, MD, USA.
Jonathan RubinSupernus Pharmaceuticals, Inc., Rockville, MD, USA.
Supernus Pharmaceuticals (United States) · USEndometriosis · GBMassachusetts General Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsFour Phase 3 studies evaluated efficacy and safety of viloxazine extended-release in the treatment of attention-deficit/hyperactivity disorder (ADHD). The primary efficacy objective-change from baseline in ADHD Rating Scale-5 (ADHD-RS-5) Total score at end of study (EOS)-was not met in one of the studies (812P304). A band-pass analysis was performed to evaluate the impact of placebo response on the results.

methodsThe distribution of placebo response at EOS of each trial was evaluated. The 2.5

resultsThe 2.5

conclusionThis analysis indicated that a higher placebo response in Study 812P304 confounded the assessment of treatment effect. Application of the band-pass methodology confirmed the positive results of the 3 prior studies and the signal detection confounder in the fourth study.

Indexed as

Attention Deficit Disorder with HyperactivityCentral Nervous System StimulantsViloxazineChildClinical Trials, Phase III as TopicDelayed-Action PreparationsDose-Response Relationship, DrugHumansOutcome Assessment, Health CarePlacebo EffectTreatment OutcomeCentral Nervous System StimulantsDelayed-Action PreparationsViloxazineADHD, ADHD-RS-5, attention-deficit/hyperactivity disorder, band-pass analysis, placebo response, treatment effect, viloxazine extended-release

Identifiers

PMID35588245
PMCPMC9796605
OpenAlexW4280489333

What OpenQuestion 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 OpenQuestion graph.