Cargando…

A Phase 3, Placebo-Controlled Trial of Once-Daily Viloxazine Extended-Release Capsules in Adolescents With Attention-Deficit/Hyperactivity Disorder

PURPOSE: This phase 3 clinical trial evaluated the efficacy and safety of viloxazine extended-release capsules (VLX-ER) as a monotherapy for attention-deficit/hyperactivity disorder (ADHD) in adolescents (12–17 years). METHODS: Eligible subjects (n = 310) were randomized to receive once-daily 200 an...

Descripción completa

Detalles Bibliográficos
Autores principales:	Nasser, Azmi, Liranso, Tesfaye, Adewole, Toyin, Fry, Nicholas, Hull, Joseph T., Busse, Gregory D., Chowdhry, Fatima, Cutler, Andrew J., Jones, Nandita Joshi, Findling, Robert L., Schwabe, Stefan
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Lippincott Williams & Wilkins 2021
Materias:	Original Contributions
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8244935/ https://www.ncbi.nlm.nih.gov/pubmed/34181360 http://dx.doi.org/10.1097/JCP.0000000000001404

Ejemplares similares

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)

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)

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

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)

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)

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)

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

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)

Population Pharmacokinetics of Viloxazine Extended‐Release Capsules in Pediatric Subjects With Attention Deficit/Hyperactivity Disorder
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)

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)

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

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

The role of placebo response in the efficacy outcome assessment in viloxazine extended‐release pivotal trials in paediatric subjects 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)

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

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

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

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

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

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)

Benefits of once-daily therapies in the treatment of hypertension
por: Flack, John M, et al.
Publicado: (2011)

Pharmacokinetics of Once‐Daily Extended‐Release Tacrolimus Tablets Versus Twice‐Daily Capsules in De Novo Liver Transplant
por: DuBay, Derek A., et al.
Publicado: (2019)

Pharmacokinetics of ADS-5102 (Amantadine) Extended Release Capsules Administered Once Daily at Bedtime for the Treatment of Dyskinesia
por: Hauser, Robert A., et al.
Publicado: (2018)

Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma
por: Woodcock, Ashley, et al.
Publicado: (2011)

Polyamide capsules via soft templating with oil drops—1. Morphological studies of the capsule wall
por: Essawy, Hisham, et al.
Publicado: (2010)

Once in a Bile — the Incidence of Bile Reflux Post-Bariatric Surgery
por: Eldredge, Thomas A., et al.
Publicado: (2022)

Once-daily dosing of gentamicin.
por: Soper, D E
Publicado: (1998)

Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma
por: O’Byrne, Paul M., et al.
Publicado: (2014)

A PK/PD study comparing twice-daily to once-daily dosing regimens of ertugliflozin in healthy subjects
por: Dawra, Vikas Kumar, et al.
Publicado: (2019)

Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma
por: O’Byrne, Paul M., et al.
Publicado: (2016)

Efficacy, Safety and Pharmacokinetics of Once-Daily Saquinavir Soft-Gelatin Capsule/Ritonavir in Antiretroviral-Naive, HIV-Infected Patients
por: Julio, Montaner SG, et al.
Publicado: (2006)

ONCE DAILY RISPERIDONE IN TREATMENT OF SCHIZOPHRENIA
por: Agarwal, Vivek, et al.
Publicado: (2001)

Conversion From Twice-Daily Tacrolimus Capsules to Once-Daily Extended-Release Tacrolimus (LCPT): A Phase 2 Trial of Stable Renal Transplant Recipients
por: Gaber, A. Osama, et al.
Publicado: (2013)

Long‐term inflammatory rosacea management with subantibiotic dose oral doxycycline 40 mg modified‐release capsules once daily
por: Del Rosso, James Q., et al.
Publicado: (2021)

Comparison of Once-Daily Bromfenac 0.07% Versus Once-Daily Nepafenac 0.3% in Patients Undergoing Phacoemulsification
por: Toyos, Melissa M.
Publicado: (2019)

Cannot write session to /tmp/vufind_sessions/sess_ihmuf8uvj5uoudvhin2p6a4gk3