A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD

Janet K. Johnson, Tesfaye Liranso, Keith Saylor, Gabriela Tulloch, Toyin Adewole, Stefan Schwabe, Azmi Nasser, Robert L. Findling, Jeffrey H. Newcorn

Research output: Contribution to journalArticle

Abstract

Objective: The objective of this study is to evaluate efficacy and safety of SPN-812 (extended-release viloxazine) for ADHD in children aged 6 to 12 years. Method: In an 8-week study, 222 participants were randomized to placebo or SPN-812 100, 200, 300, or 400 mg/day. Measurements included ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores. Safety assessments included laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting. Results: Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo (p <.05; effect size [ES] = 0.547, 0.596, and 0.623). CGI-I score for the 300 mg group and CGI-S score for all SPN-812 groups except for 100 mg improved significantly (p <.05) versus placebo. The most frequent AEs (≥15%) were somnolence, headache, and decreased appetite. Conclusion: SPN-812 significantly reduced the severity of ADHD symptoms and was well tolerated. The efficacy and safety of SPN-812 are being investigated in Phase III trials.

Original languageEnglish (US)
Pages (from-to)348-358
Number of pages11
JournalJournal of Attention Disorders
Volume24
Issue number2
DOIs
StatePublished - Jan 1 2020

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Keywords

  • ADHD
  • attention deficit/hyperactivity disorder
  • nonstimulant
  • viloxazine

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Clinical Psychology

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