SPN-812 for Preschool-age Children With ADHD
This study is testing SPN-812 (viloxazine extended-release capsule) in children aged 4 to 5 years old who have Attention-Deficit/Hyperactivity Disorder (ADHD). We want to see if SPN-812 is safe and effective in reducing ADHD symptoms compared to a placebo (an inactive pill). Success in this study will be measured by changes in ADHD symptoms, as reported on a specific rating scale (ADHD-RS-IV-P), after 6 weeks of treatment. The study plans to enroll 286 children. The current status of the study is unclear, so it's not known if they are actively recruiting participants at this time.
- Study design
- This is a randomized, double-blind study where participants will either receive SPN-812 or a placebo. About 286 children will participate.
- What's involved
- You would be screened for up to 4 weeks, then receive study medication for 6 weeks. The total time in the study is up to 10 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measure of success is taken at the end of the 6-week treatment period.
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Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
At a glance
Conditions
Where it's being run
47 sites across 24 statesStudy leadership
- Jonathan Rubin, MD, MBA · STUDY_DIRECTOR · Supernus Pharmaceuticals, Inc.
Who to contact
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What this trial 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)Baseline and Week 6
The Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) consists of 18 items that correspond directly to the DSM-IV-TR criteria for ADHD. The scale is subdivided into two subscales: inattention ("IA", 9 items) and hyperactivity-impulsivity ("H/I", 9 items).The clinician rates the frequency and severity of each symptom on a 4-point Likert-type scale, where 0 = Never or rarely, 1 = Sometimes, 2 = Often, and 3 = Very often. The sum of the ratings of all 18 items yields the raw Total score (range: 0-54; the higher the Total score, the more severe the ADHD symptoms). Post-baseline raw Total scores are converted to a change from baseline Total score. A lower change from baseline ADHD-RS-IV-P Total Score (\<0) represents a better outcome.