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Artigos Científicos

sexta-feira, 29 março 2019 16:37

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

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Janet K. Johnson1, Tesfaye Liranso2, Keith Saylor3, Gabriela Tulloch1, Toyin Adewole2, Stefan Schwabe2, Azmi Nasser2, Robert L. Findling4,5, Jeffrey H. Newcorn6

Formerly at Supernus Pharmaceuticals, Inc., Rockville, MD, USA
Supernus Pharmaceuticals, Inc., Rockville, MD, USA
NeuroScience, Inc., Herndon, VA, USA
Johns Hopkins University, Baltimore, MD, USA
Kennedy Krieger Institute, Baltimore, MD, USA
Icahn School of Medicine at Mount Sinai, New York, NY, USA

Journal of Attention Disorders: SAGE Journals

March 29, 2019


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.

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