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 week 6

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 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)

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