drugset

drugset / Trial / NCT04143217

Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD

NCT04143217 ↗

Phase 3 Completed 159 enrolled Supernus Pharmaceuticals, Inc.

NaSingle-groupOpen-labelTreatment

Summary

Open label, flexible dose, long-term multicenter study of safety and efficacy of SPN-812 in adult ADHD patients

Timeline

Start: 2020-01-23
Primary completion: 2022-07-26
Completion: 2022-12-14

Publications

Childress A, Cutler AJ, Adler LA, Fry N, Asubonteng K, Maldonado-Cruz Z, Formella A, Rubin J. An Open-Label Extension Study Assessing the Long-Term Safety and Efficacy of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2024 Nov;38(11):891-907. doi: 10.1007/s40263-024-01120-0. Epub 2024 Oct 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Viloxazine	Small molecule	200 mg	—
Subject	Viloxazine	Small molecule	600 mg	—

Indications