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

Phase 3CompletedNCT02083783

Tris Pharma, Inc.108 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

TRI102DRUG

formulation containing active moiety (amphetamine)

PlaceboOTHER

formulation without active moiety

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (5)

Newport Beach Clinical Research Associates, Inc.

Newport Beach, California, United States

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, United States

Duke University Medical Center

Durham, North Carolina, United States

Bayou City Research

Houston, Texas, United States

Outcomes

Primary Outcomes

SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale)

Change from baseline in SKAMP-Combined Scores measured approximately 4 hours after dose (active or placebo). The SKAMP-Combined score is obtained by summing 13 assessment items, where each item is rated on a 7-point scale (0 = normal to 6 = maximal impairment). This gives an overall (combined) SKAMP Score of 0= normal to 78 which indicates maximal impairment. The endpoint is assessed as a change from baseline in the overall score on the 78-point scale.

Time frame: Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose

Secondary Outcomes

PERMP (Permanent Product Measure of Performance).

The PERMP is a math test that measures effortful performance without a learning curve (Wigal and Wigal 2006). The test determines the number of problems attempted and the number of problems correctly answered. In this study, the primary efficacy measure was a PERMP evaluation done 4 hours after taking study medication, a time selected a priori to coincide with the known pharmacodynamic effects based on prior research and to minimize the impact of repeated measures on adjustment of multiplicity (Wigal et al. 1998; Pelham et al. 2001). The PERMP consists of 400 math questions and each are scored. PERMP scores are expressed as the number of questions correct. Predose PERMP Tests are compared with post-dose PERMP scores at prespecfied timepoints.

Time frame: Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose.

Data from ClinicalTrials.gov

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