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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

1
Formerly at Supernus Pharmaceuticals, Inc., Rockville, MD, USA
2
Supernus Pharmaceuticals, Inc., Rockville, MD, USA
3
NeuroScience, Inc., Herndon, VA, USA
4
Johns Hopkins University, Baltimore, MD, USA
5
Kennedy Krieger Institute, Baltimore, MD, USA
6
Icahn School of Medicine at Mount Sinai, New York, NY, USA

Journal of Attention Disorders: SAGE Journals

March 29, 2019


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.


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