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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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A Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter, laboratory classroom study. After Screening and Baseline evaluations, eligible subjects are enrolled in the study and entered the open-label phase, dose-optimization phase. TRI102 is taken once daily and subjects undergo dose optimization activities for 5 weeks.

Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TRI102

Active, amphetamine extended-release oral suspension

Group Type EXPERIMENTAL

TRI102

Intervention Type DRUG

formulation containing active moiety (amphetamine)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

formulation without active moiety

Interventions

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TRI102

formulation containing active moiety (amphetamine)

Intervention Type DRUG

Placebo

formulation without active moiety

Intervention Type OTHER

Other Intervention Names

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amphetamine extended-release oral suspension

Eligibility Criteria

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Inclusion Criteria

* Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

Exclusion Criteria

* Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No