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Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

NCT04781140 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2026-02-18

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.

Conditions

  • Attention-Deficit/Hyperactivity Disorder

Interventions

DRUG

100mg SPN-812

100mg SPN-812 will be administered once daily and compared to Placebo

DRUG

Placebo

Placebo will be administered once daily

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan Rubin, MD, MBA · Supernus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
48 Months
Max Age
69 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-19
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04781140 on ClinicalTrials.gov