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

NCT02083783 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-08-26

Study results available
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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.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

TRI102

formulation containing active moiety (amphetamine)

OTHER

Placebo

formulation without active moiety

Sponsors & Collaborators

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Sharon Wigal, PhD · Newport Beach Clinical Research Associates, Inc.

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
2014-03-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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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 NCT02083783 on ClinicalTrials.gov