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Norepinephrine Reuptake Inhibitor

SPN-812 for ADHD

Phase 4
Recruiting
Research Sponsored by Supernus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trial will test how well and how safe a medication called SPN-812 (viloxazine extended release) is for treating ADHD in children between 4 and 5 years old.

Who is the study for?
This trial is for medically healthy boys and girls aged between 4 years and 5 years 9 months with ADHD, as per DSM-IV-TR criteria. They must have a certain severity of symptoms, be in structured group activities like preschool, and not currently undergoing behavioral interventions for ADHD.
What is being tested?
The study tests the effectiveness and safety of SPN-812 (viloxazine extended release) compared to a placebo in managing ADHD symptoms in preschool-age children. The goal is to see if this medication can help improve their attention and behavior.
What are the potential side effects?
While specific side effects are not listed here, common side effects for ADHD medications may include decreased appetite, stomach pain, sleep problems, headaches, or mood changes. Each child's experience with side effects can vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Total Score at End of Study (Week 6)
Secondary study objectives
Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Responder Rate (percentage of subjects with ≥ 50% Reduction in Change from Baseline) at End of Study (Week 6)
Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Hyperactivity/Impulsivity Subscale Score at End of Study (Week 6)
Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Inattention Subscale Score at End of Study (Week 6)
+4 more

Side effects data

From 2018 Phase 3 trial • 477 Patients • NCT03247530
10%
Headache
9%
Somnolence
9%
Decreased appetite
6%
Sedation
5%
Vomiting
5%
Nasopharyngitis
1%
Appendicitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
200mg SPN-812
100mg SPN-812

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SPN-812Experimental Treatment1 Intervention
SPN-812, qd
Group II: PlaceboPlacebo Group1 Intervention
Placebo, qd
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
100mg SPN-812
2017
Completed Phase 3
~700

Find a Location

Who is running the clinical trial?

Supernus Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
13,606 Total Patients Enrolled
18 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
5,704 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Jonathan Rubin, MD, MBAStudy DirectorSupernus Pharmaceuticals, Inc.
5 Previous Clinical Trials
1,911 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,496 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
~191 spots leftby Dec 2025
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