Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
Evaluation of the Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD - A Double-Blind, Placebo-Controlled, Dose-Ranging Study
Sponsor: Supernus Pharmaceuticals, Inc.
A PHASE2 clinical study on Attention-Deficit/Hyperactivity Disorder (ADHD), this trial is completed. The trial is conducted by Supernus Pharmaceuticals, Inc. and has accumulated 9 data snapshots since 2016. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.
Study Description(click to expand)This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).
This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).
Status Flow
Change History
9 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Nov 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Nov 2021 [monthly]
Completed PHASE2
-
Sep 2020 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 4 earlier versions
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Jun 2018 — Sep 2020 [monthly]
Completed PHASE2
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Jun 2017 — Jun 2018 [monthly]
Completed PHASE2
Status: Recruiting → Completed
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Feb 2017 — Jun 2017 [monthly]
Recruiting PHASE2
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE2
First recorded
Feb 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Supernus Pharmaceuticals, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .