Supernus 812P401 (Childhood ADHD)

Purpose of this Study

We are doing this study to find out if an investigational, non-stimulant drug called SPN-812 (the study drug, viloxazine extended-release capsules). The study drug is FDA-approved for children ages 6 and above. It is not approved for children younger than 6, so this study is being done to determine how well it works and how safe it is for preschool-aged children.

Who Can Participate?

Eligibility

Children ages 48-69 months who:
  • Shows signs of hyperactivity, impulsivity, and inattention
  • Are attending a group activity outside of the home (such as preschool, sports, camps or childcare)
  • Have an ADHD diagnosis confirmed at the first visit
For more information, contact the study team at matthew.gibson646@duke.edu.

Age Range

4-5

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to have your child join this study, you and/or they will:
  • Take the study drug or a placebo(inactive substance) once each day for 6 weeks
  • Make a weekly visit to our clinic while your child takes the study drug or placebo
  • Return to our clinic for follow-up visits after your child discontinues the study drug or placebo
The study will last for about 10 weeks. Your child will get their assignment to take the study drug or placebo at random (like a coin flip). At each of the study visits, you will meet with a clinical psychologist to discuss your child's behavior. We will perform physical examinations and take vital signs during the visits. This includes blood pressure, height, weight, and temperature. We will perform a 12-Lead electrocardiogram (ECG) at the first and last visit, which uses sticky pads placed on the chest to measure the heart's electrical activity. We will collect blood samples at the first and last study visit.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 years old) with Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Website

Study Website

Principal Investigator

Rachel
Dew

Protocol Number

PRO00115985

NCT ID

NCT04781140

Phase

IV

Enrollment Status

Open to Enrollment
ClinicalTrials.gov