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Norepinephrine Reuptake Inhibitor

SPN-812 for Attention Deficit Hyperactivity Disorder (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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Somnolence

Decreased appetite

Sedation

Vomiting

Nasopharyngitis

Appendicitis

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Supernus Pharmaceuticals, Inc.Lead Sponsor

47 Previous Clinical Trials

13,512 Total Patients Enrolled

18 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

5,468 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Jonathan Rubin, MD, MBAStudy DirectorSupernus Pharmaceuticals, Inc.

4 Previous Clinical Trials

475 Total Patients Enrolled

1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

60 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has SPN-812 received the stamp of approval from the FDA?

"Given that this investigation is in Phase 4, indicating official approval for usage, the safety rating of SPN-812 by our team at Power stands at the highest level of 3."

Answered by AI

Are individuals who are older than 18 years of age eligible to enroll in this medical study?

"Eligible candidates for this clinical trial must fall within the age range of 48 to 69 months. Among the available trials, there are 121 focused on individuals below 18 years old and 40 targeting those over 65 years old."

Answered by AI

Are there any available positions for participants in this research study?

"Indeed, data on clinicaltrials.gov confirms the active recruitment status of this trial. The clinical trial was initially uploaded on March 19th, 2024 and last modified on March 22nd, 2024. A total of 286 participants are sought from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04781140.

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