NCT04786990

Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD

A Phase IV, Open-Label, Flexible-Dose Safety Trial Evaluating SPN-812 Administered With Psychostimulants in Children and Adolescents (6 to 17 Years of Age) With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is an open-label, multicenter, flexible-dose, safety study of SPN-812 in pediatric patients (6-17 years of age) diagnosed with ADHD, when administered with a FDA-approved medication (psychostimulant) in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric subjects. Participants will be screened for eligibility for up to 4 weeks, and he/she will continue to take their prescribed psychostimulant ADHD medication during that time. Following the screening period, eligible subjects will receive SPN-812 with their current psychostimulant treatment for ADHD for 8 weeks. For the first 4 weeks of treatment subjects will take SPN-812 dose in the morning (AM dosing), and for the last 4 weeks of treatment, subjects will take SPN-812 dose in the evening (PM dosing). The total duration of the study between the screening visit and the end of the treatment period/end of study (EOS) visit is up to 12 weeks.

Conditions

• Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	SPN-812	Viloxazine extended-release capsule

Timeline

• Start date: 2021-07-27
• Primary completion: 2023-05-23
• Completion: 2023-07-26
• First posted: 2021-03-08
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

17 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study