NCT01835548

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

A Randomized, Multicenter, Double-Blind, Placebo Controlled, Parallel Group Study of NT0102 in Children (Ages 6 12 Years) With Attention-Deficit Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Neos Therapeutics, Inc · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	NT0102	NT0102 (methylphenidate polistirex \[MPP\] extended release \[XR\] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride.
DRUG	Placebo	Matching ODT placebo was given once daily.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-04-19
• Last updated: 2018-01-17
• Results posted: 2018-01-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study