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SPN-812

DRUG5 trials

Sponsors

Supernus Pharmaceuticals, Inc.

Conditions

Attention-Deficit/Hyperactivity DisorderAttention-Deficit/Hyperactivity Disorder (ADHD)

Phase 3

Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)
Active, not recruitingNCT02736656
Supernus Pharmaceuticals, Inc.Attention-Deficit/Hyperactivity Disorder
Start: 2016-02-02End: 2026-09-01Target: 1400Updated: 2026-07-15
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
CompletedNCT04016779
Supernus Pharmaceuticals, Inc.Attention-Deficit/Hyperactivity Disorder (ADHD)
Start: 2019-11-20End: 2020-10-10Updated: 2022-07-12
Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
CompletedNCT04143217
Supernus Pharmaceuticals, Inc.Attention-Deficit/Hyperactivity Disorder
Start: 2020-01-23End: 2022-12-14Updated: 2024-02-13

Phase 4

Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD
CompletedNCT04786990
Supernus Pharmaceuticals, Inc.Attention-Deficit/Hyperactivity Disorder (ADHD)
Start: 2021-07-27End: 2023-07-26Updated: 2024-05-01
Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms
CompletedNCT06185985
Supernus Pharmaceuticals, Inc.Attention-Deficit/Hyperactivity Disorder
Start: 2024-03-25End: 2024-12-11Updated: 2026-03-27

Related Papers

Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Results of a Long-Term, Phase 3, Open-Label Extension Trial
CNS Drugs2025-08-13
An Open-Label Extension Study Assessing the Long-Term Safety and Efficacy of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder.
2024-10-071 citations
Qelbree (viloxazine extended-release capsules): Final Results of the Long-Term, Phase 3, Open-Label Extension Trial in Adults with ADHD
CNS Spectrums2024-10-012 citations
Efficacy of Viloxazine ER (Qelbree) for ADHD in Adults Based on Prior Stimulant Exposure
CNS Spectrums2024-10-011 citations
Evaluating Viloxazine ER (Qelbree) Administered with Psychostimulants For Pediatric ADHD: Analysis of a Phase 4 Safety Trial
CNS Spectrums2024-10-01
Viloxazine Extended-Release Capsules in Children and Adolescents with ADHD: Final Results of a Long-Term, Phase 3, Open-Label Extension Study
CNS Spectrums2024-10-01
Assessment of centanafadine in adults with attention-deficit/hyperactivity disorder: A matching-adjusted indirect comparison vs lisdexamfetamine dimesylate, atomoxetine hydrochloride, and viloxazine extended-release
Journal of Managed Care & Specialty Pharmacy2024-06-017 citations
Evaluating the Impact of Caffeine on the Incidence of Adverse Events During Treatment with Viloxazine Extended-Release (Qelbree®) in Adults with ADHD
CNS Spectrums2023-04-012 citations
Impact of Viloxazine Extended-Release Capsules (Qelbree®) on Executive Function in Adults With ADHD During an Open-Label Extension Study
CNS Spectrums2023-04-011 citations
Effects of Viloxazine ER (Qelbree®) on Weight and Height Trajectories: Interim Results From a Long-term, Open-Label Extension Trial in Pediatric ADHD
CNS Spectrums2023-04-011 citations
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder.
2022-07-2730 citations
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
Journal of Child and Adolescent Psychopharmacology2021-02-1818 citations