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

Study Overview
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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.

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.

Official Title
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TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHA): A Laboratory Classroom Study

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: TRI102
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRI102<br>Active, amphetamine extended-release oral suspension | Drug: TRI102<br>* formulation containing active moiety (amphetamine)<br>* Other names: amphetamine extended-release oral suspension;|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* formulation without active moiety<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose. |