Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD

Summary

This study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents (12-17 years old) with ADHD

Timeline

Start

2017-11-20

Primary completion

2019-02-14

Completion

2019-02-14

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Lower change from baseline scores (<0) represent a better outcome. reads as mixed primary results NCT03247556 ↗

registry analysis (superiority test); Placebo vs 400mg SPN-812; p = 0.0082; Least Square Mean Difference -5.1 (95% CI -8.9 to -1.3) reads as mixed primary results NCT03247556 ↗

registry analysis (superiority test); Placebo vs 600mg SPN-812; p = 0.0712; Least Square Mean Difference -3.5 (95% CI -7.3 to 0.3) reads as mixed primary results NCT03247556 ↗

release “P304 Phase III Topline Results At the end of the study (EOS), SPN-812 400 mg reached statistical significance compared to placebo in the primary endpoint.” reads as met primary endpoint supernus.com ↗

Publications

• Faraone SV, Gomeni R, Hull JT, Busse GD, Lujan B, Rubin J, Nasser A. Response of peer relations and social activities to treatment with viloxazine extended-release capsules (Qelbree(R) ): A post hoc analysis of four randomized clinical trials of children and adolescents with attention-deficit/hyperactivity disorder. Brain Behav. 2023 Apr;13(4):e2910. doi: 10.1002/brb3.2910. Epub 2023 Feb 27.
• Faraone SV, Gomeni R, Hull JT, Busse GD, Melyan Z, Rubin J, Nasser A. 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. Paediatr Drugs. 2021 Nov;23(6):583-589. doi: 10.1007/s40272-021-00470-2. Epub 2021 Sep 15.
• Nasser A, Kosheleff AR, Hull JT, Liranso T, Qin P, Busse GD, Fava M, Maletic V, Rubin J, Lopez F. Evaluating the likelihood to be helped or harmed after treatment with viloxazine extended-release in children and adolescents with attention-deficit/hyperactivity disorder. Int J Clin Pract. 2021 Aug;75(8):e14330. doi: 10.1111/ijcp.14330. Epub 2021 May 26.
• Nasser A, Kosheleff AR, Hull JT, Liranso T, Qin P, Busse GD, O'Neal W, Fava M, Faraone SV, Rubin J. 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. J Child Adolesc Psychopharmacol. 2021 Apr;31(3):214-226. doi: 10.1089/cap.2020.0148. Epub 2021 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Viloxazine	Small molecule	400 mg	Oral
Subject	Viloxazine	Small molecule	600 mg	Oral

Indications