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

NCT02083783 ↗

Phase 3 Completed 108 enrolled Tris Pharma, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2014-03
Primary completion: 2014-10
Completion: 2014-12

Outcome

Met primary endpoint

registry MEAN TRI102: -9.1 (Standard Deviation 7.51) score on a scale MEAN Placebo: 5.6 (Standard Deviation 7.85) score on a scale NCT02083783 ↗

registry analysis (superiority test); TRI102 vs Placebo; p <0.0001; Mean Difference (Final Values) -14.68 (95% CI -17.9 to 11.6); ANCOVA NCT02083783 ↗

Publications

Faraone SV, Childress AC, Gomeni R, Rafla E, Kando JC, Dansie L, Naik P, Pardo A. Efficacy of Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder: Effect Size Across the Day. J Child Adolesc Psychopharmacol. 2023 Feb;33(1):14-19. doi: 10.1089/cap.2022.0093. Epub 2023 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amphetamine	Unknown	—	Oral