The role of placebo response in the efficacy outcome assessment in viloxazine extended-release pivotal trials in paediatric subjects with attention-deficit/hyperactivity disorder.
Attention Deficit Disorder with Hyperactivity
/ drug therapy
Central Nervous System Stimulants
Child
Clinical Trials, Phase III as Topic
Delayed-Action Preparations
/ therapeutic use
Dose-Response Relationship, Drug
Humans
Outcome Assessment, Health Care
Placebo Effect
Treatment Outcome
Viloxazine
/ therapeutic use
ADHD, ADHD-RS-5, attention-deficit/hyperactivity disorder, band-pass analysis, placebo response, treatment effect, viloxazine extended-release
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
11 2022
11 2022
Historique:
revised:
22
04
2022
received:
22
07
2021
accepted:
06
05
2022
pubmed:
20
5
2022
medline:
14
10
2022
entrez:
19
5
2022
Statut:
ppublish
Résumé
Four 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. The distribution of placebo response at EOS of each trial was evaluated. The 2.5 The 2.5 This 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.
Identifiants
pubmed: 35588245
doi: 10.1111/bcp.15412
pmc: PMC9796605
doi:
Substances chimiques
Central Nervous System Stimulants
0
Delayed-Action Preparations
0
Viloxazine
5I5Y2789ZF
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
4828-4838Informations de copyright
© 2022 Supernus Pharmaceuticals, Inc. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.
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