NCT06185985

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

A Phase IV, Open-Label, Decentralized Clinical Trial to Evaluate the Efficacy and Safety of Qelbree® in Adults With Attention-Deficit/Hyperactivity Disorder and Mood Symptoms

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Open label, flexible dose, decentralized clinical trial evaluating the efficacy and safety of SPN-812 in adults with ADHD and mood symptoms.

Detailed description

This is a Phase IV, open-label, flexible dose, decentralized clinical trial to evaluate the efficacy and safety of SPN-812 in adults with ADHD and mood symptoms. Adults 18 years and older with ADHD will be recruited, consented and screened for eligibility. Following the Screening Period (up to 4 weeks), eligible participants will be treated with Study medication for up to 14 weeks (Treatment Period). The total study duration is approximately 18 weeks, and there are up to 6 virtual study visits (or Televisits). All Televisits are conducted via an application downloaded to participant's mobile phone. There are up to 2 Televisits during the Screening period and 3 Televisits during the Treatment period. Subjects initiate SPN-812 dosing at 200 mg once daily during first week and then titrate up to 400 mg once daily during the second week. At the Investigator's discretion, based on subject's clinical response and tolerability, the dose of SPN-812 can be increased or decreased to optimal dose within the range between 200 and 600 mg once daily during the remaining Treatment period. Participants will answer questions during structured clinical interviews with an investigator during Televisits and complete additional questionnaires and scales via the mobile app.

Conditions

• Attention-Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	SPN-812	Open-label

Timeline

• Start date: 2024-03-25
• Primary completion: 2024-12-03
• Completion: 2024-12-11
• First posted: 2023-12-29
• Last updated: 2026-03-27
• Results posted: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study