CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 87 enrolled
Drug / intervention
NT0102 +1 moredrug
Likely dose
NT0102 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01835548
NCT01835548Phase 3Completed
CompareCT.gov

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

Neos Therapeutics, Inc·interventional·Posted Apr 19, 2013·Updated Jan 17, 2018

In Brief

A Phase 3 clinical trial evaluating NT0102 and Placebo for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 87 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder (ADHD)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2013
Enrollment StartJul 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.2 years ago

Interventions

NT0102drug

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

Placebodrug

Matching ODT placebo was given once daily.