TY  - JOUR
PY  - 2020//
TI  - A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD
JO  - Journal of attention disorders
A1  - Johnson, Janet K.
A1  - Liranso, Tesfaye
A1  - Saylor, Keith
A1  - Tulloch, Gabriela
A1  - Adewole, Toyin
A1  - Schwabe, Stefan
A1  - Nasser, Azmi
A1  - Findling, Robert L.
A1  - Newcorn, Jeffrey H.
SP  - 348
EP  - 358
VL  - 24
IS  - 2
N2  - 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. <br><br>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. <br><br>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. <br><br>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.<p /> <p>Language: en</p>
LA  - en
SN  - 1087-0547
UR  - http://dx.doi.org/10.1177/1087054719836159
ID  - ref1
ER  -