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

NCT01835548 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2018-01-17

Study results available
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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

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.

Sponsors & Collaborators

  • Neos Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Carolyn Sikes, PhD · Neos Tx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-07-31
Completion
2014-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01835548 on ClinicalTrials.gov