NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

Summary

This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory classroom study.

Timeline

Start

2013-07

Primary completion

2014-07

Completion

2014-07

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs NT0102; p <0.0001; Least Square Mean Difference -11.04 (95% CI -13.9 to -8.20); ANCOVA NCT01835548 ↗

Publications

• Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR. Open-Label Dose Optimization of Methylphenidate Extended-Release Orally Disintegrating Tablet in a Laboratory Classroom Study of Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Jun;31(5):342-349. doi: 10.1089/cap.2020.0142. Epub 2021 Jun 2.
• Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR. Efficacy, Safety, and Tolerability of an Extended-Release Orally Disintegrating Methylphenidate Tablet in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder in the Laboratory Classroom Setting. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):66-74. doi: 10.1089/cap.2016.0002. Epub 2016 May 16.

Drugs

Indications