drugset / Trial / NCT04786990
Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD
NaSingle-groupOpen-labelTreatment
Summary
This open label, flexible-dose study evaluating the safety and efficacy of SPN-812 administered with psychostimulants in children and adolescents (6 to 17 years of age) with Attention-Deficit/Hyperactivity Disorder (ADHD).
Timeline
- Start
- 2021-07-27
- Primary completion
- 2023-05-23
- Completion
- 2023-07-26
Outcome
Met primary endpoint
release “Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant.” supernus.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Viloxazine | Small molecule | 100 mg | Oral |
| Subject | Viloxazine | Small molecule | 200 mg | Oral |
| Subject | Viloxazine | Small molecule | 400 mg | Oral |
| Subject | Viloxazine | Small molecule | 600 mg | Oral |