NCT02083783

TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHA): A Laboratory Classroom Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether TRI102 is effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.

Detailed description

A Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter, laboratory classroom study. After Screening and Baseline evaluations, eligible subjects are enrolled in the study and entered the open-label phase, dose-optimization phase. TRI102 is taken once daily and subjects undergo dose optimization activities for 5 weeks.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	TRI102	formulation containing active moiety (amphetamine)
OTHER	Placebo	formulation without active moiety

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-03-11
• Last updated: 2020-08-26
• Results posted: 2020-08-26

Locations

5 sites across 1 country: United States