Cargando…

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

Aims: 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...

Descripción completa

Detalles Bibliográficos
Autores principales:	Nasser, Azmi, Gomeni, Roberto, Wang, Zhao, Hull, Joseph T., Busse, Gregory D., Melyan, Zare, Fava, Maurizio, O'Neal, Welton, Rubin, Jonathan
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2022
Materias:	Original Articles
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9796605/ https://www.ncbi.nlm.nih.gov/pubmed/35588245 http://dx.doi.org/10.1111/bcp.15412

Ejemplares similares

A post hoc analysis of the effect of viloxazine extended-release capsules on learning and school problems in children and adolescents with attention-deficit/hyperactivity disorder
por: Faraone, Stephen V., et al.
Publicado: (2021)

Executive Function Outcome of Treatment with Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Post-Hoc Analysis of Four Randomized Clinical Trials
por: Faraone, Stephen V., et al.
Publicado: (2021)

The Effect of Viloxazine Extended-Release Capsules on Functional Impairments Associated with Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents in Four Phase 3 Placebo-Controlled Trials
por: Nasser, Azmi, et al.
Publicado: (2021)

Translating Attention-Deficit/Hyperactivity Disorder Rating Scale-5 and Weiss Functional Impairment Rating Scale-Parent Effectiveness Scores into Clinical Global Impressions Clinical Significance Levels in Four Randomized Clinical Trials of SPN-812 (Viloxazine Extended-Release) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
por: Nasser, Azmi, et al.
Publicado: (2021)

Evaluating the likelihood to be helped or harmed after treatment with viloxazine extended‐release in children and adolescents with attention‐deficit/hyperactivity disorder
por: Nasser, Azmi, et al.
Publicado: (2021)

Response of peer relations and social activities to treatment with viloxazine extended‐release capsules (Qelbree(®)): A post hoc analysis of four randomized clinical trials of children and adolescents with attention‐deficit/hyperactivity disorder
por: Faraone, Stephen V., et al.
Publicado: (2023)

Population Pharmacokinetics of Viloxazine Extended‐Release Capsules in Pediatric Subjects With Attention Deficit/Hyperactivity Disorder
por: Nasser, Azmi, et al.
Publicado: (2021)

A Phase 3, Placebo-Controlled Trial of Once-Daily Viloxazine Extended-Release Capsules in Adolescents With Attention-Deficit/Hyperactivity Disorder
por: Nasser, Azmi, et al.
Publicado: (2021)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder
por: Nasser, Azmi, et al.
Publicado: (2022)

Authors’ Reply to Singh and Balasundaram: Comment on “A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder”
por: Nasser, Azmi, et al.
Publicado: (2022)

Viloxazine in the Treatment of Attention Deficit Hyperactivity Disorder
por: Edinoff, Amber N., et al.
Publicado: (2021)

Viloxazine in the Management of CNS Disorders: A Historical Overview and Current Status
por: Findling, Robert L., et al.
Publicado: (2021)

Extended-Release Viloxazine Compared with Atomoxetine for Attention Deficit Hyperactivity Disorder
por: Price, Maxwell Z., et al.
Publicado: (2023)

Predicted Efficacy of Once-Daily Extended-Release Oxcarbazepine (Oxtellar XR(®)) Monotherapy in Adults and Children with Partial-Onset Seizures: Exposure-Response Modeling and Simulation
por: Faison, Shamia, et al.
Publicado: (2020)

Authors’ Reply to Pande et al. Comment on “Extended-Release Viloxazine Compared to Atomoxetine for Attention Deficit Hyperactivity Disorder”
por: Price, Maxwell Z., et al.
Publicado: (2023)

Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Lisdexamfetamine in Healthy Adults
por: Faison, Shamia L., et al.
Publicado: (2021)

Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Methylphenidate in Healthy Adults
por: Faison, Shamia L., et al.
Publicado: (2020)

Viloxazine for Attention-Deficit Hyperactivity Disorder: A Systematic Review and Meta-analysis of Randomized Clinical Trials
por: Singh, Alok, et al.
Publicado: (2022)

A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD
por: Johnson, Janet K., et al.
Publicado: (2019)

Artificial intelligence approach for the analysis of placebo-controlled clinical trials in major depressive disorders accounting for individual propensity to respond to placebo
por: Gomeni, Roberto, et al.
Publicado: (2023)

Viloxazine: Pediatric First Approval
por: Lamb, Yvette N.
Publicado: (2021)

Correction to: Viloxazine: Pediatric First Approval
por: Lamb, Yvette N.
Publicado: (2023)

Impact of a High-Fat Meal and Sprinkled Administration on the Bioavailability and Pharmacokinetics of Viloxazine Extended-Release Capsules (Qelbree(TM)) in Healthy Adult Subjects
por: Wang, Zhao, et al.
Publicado: (2021)

Impact of Paroxetine, a Strong CYP2D6 Inhibitor, on SPN‐812 (Viloxazine Extended‐Release) Pharmacokinetics in Healthy Adults
por: Wang, Zhao, et al.
Publicado: (2021)

Model-Based Approach for Establishing the Predicted Clinical Response of a Delayed-Release and Extended-Release Methylphenidate for the Treatment of Attention-Deficit/Hyperactivity Disorder
por: Gomeni, Roberto, et al.
Publicado: (2020)

Efficacy of Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder: Effect Size Across the Day
por: Faraone, Stephen V., et al.
Publicado: (2023)

New Insights into the Mechanism of Action of Viloxazine: Serotonin and Norepinephrine Modulating Properties
por: Yu, Chungping, et al.
Publicado: (2020)

The Impact of Persistent Irritability on the Medication Treatment of Paediatric Attention Deficit Hyperactivity Disorder
por: Baweja, Raman, et al.
Publicado: (2021)

Chiropractic care for paediatric and adolescent Attention-Deficit/Hyperactivity Disorder: A systematic review
por: Karpouzis, Fay, et al.
Publicado: (2010)

A Novel Assessment Tool for Impulsive Aggression in Children with Attention-Deficit/Hyperactivity Disorder
por: Ceresoli-Borroni, Gianpiera, et al.
Publicado: (2019)

Neural dysfunction during temporal discounting in paediatric Attention-Deficit/Hyperactivity Disorder and Obsessive-Compulsive Disorder
por: Norman, Luke J., et al.
Publicado: (2017)

Evaluation of Attention-Deficit Hyperactivity Disorder Risk Factors
por: Golmirzaei, Javad, et al.
Publicado: (2013)

Randomized, Double-Blind, Placebo-Controlled Acute Comparator Trials of Lisdexamfetamine and Extended-Release Methylphenidate in Adolescents With Attention-Deficit/Hyperactivity Disorder
por: Newcorn, Jeffrey H., et al.
Publicado: (2017)

Efficacy of atomoxetine in adult attention-Deficit/Hyperactivity Disorder: a drug-placebo response curve analysis
por: Faraone, Stephen V, et al.
Publicado: (2005)

A comparison of the effects of reboxetine and placebo on reaction time in adults with Attention Deficit-Hyperactivity Disorder (ADHD)
por: Hashemian, F, et al.
Publicado: (2011)

Analysis of individual items on the attention-deficit/hyperactivity disorder symptom rating scale in children and adults: the effects of age and sex in pivotal trials of lisdexamfetamine dimesylate
por: Weisler, Richard H, et al.
Publicado: (2013)

Efficacy and Safety of Dextroamphetamine Transdermal System for the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Results from a Pivotal Phase 2 Study
por: Cutler, Andrew J., et al.
Publicado: (2022)

Convolution-based approach for modeling the paliperidone extended release and Long-Acting Injectable (LAI) PK of once-, and three-monthly products administration and for optimizing the development of new LAI products
por: Gomeni, Roberto, et al.
Publicado: (2022)

Multiple Intelligences Profiles of Children with Attention Deficit and Hyperactivity Disorder in Comparison with Nonattention Deficit and Hyperactivity Disorder
por: Najafi, Mostafa, et al.
Publicado: (2017)

The Role of Lead Exposure on Attention-Deficit/ Hyperactivity Disorder ‎in Children: A Systematic Review
por: Daneshparvar, Maryam, et al.
Publicado: (2016)

Cannot write session to /tmp/vufind_sessions/sess_d7u2jkuf23hs2nll10gsbqo77c