NCT00626236

Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems

A Randomized, Multicenter, Parallel Group, Dose-Ranging Study to Evaluate the Safety and Tolerability of SPN-810 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Persistent Serious Conduct Problems

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective was to evaluate the safety and tolerability of four doses of SPN-810 in children with ADHD and persistent serious conduct problems.

Detailed description

This will be a randomized, multicenter, parallel group, dose-ranging safety and tolerability study in children with ADHD and persistent serious conduct problems. The target subjects are healthy male or female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD with persistent serious conduct problems. To determine eligibility for the study, subjects will undergo an initial screening visit. Seventy-two subjects will be randomized in the study; assuming a 17% dropout rate, it is anticipated that 60 subjects will complete the study. The study will consist of a Screening Period (within 28 days prior to the first dose administration), a Titration Period of 2 to 5 weeks, a Maintenance Period of 6 weeks, and a Safety Follow-up, which will be performed 30 days after the final study visit. The total subject duration in the study will be 16 to 19 weeks depending on the treatment group assignment. The total study duration is anticipated to be 15.5 months. A total of 72 subjects will be randomized based on weight at baseline, to 1 of 4 treatment groups.

Conditions

• Attention Deficit Disorder With Hyperactivity
• Conduct Disorder

Interventions

Type	Name	Description
DRUG	SPN-810	1.67mg capsule taken TID
DRUG	SPN-810	3.33mg capsule taken TID
DRUG	SPN-810	5mg capsule taken TID
DRUG	SPN-810	6.67 mg capsule taken TID

Timeline

• Start date: 2008-10-21
• Primary completion: 2009-09-23
• Completion: 2009-09-23
• First posted: 2008-02-29
• Last updated: 2025-12-09
• Results posted: 2025-09-16

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study