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

Phase 3

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Other: Placebo; Drug: TRI102

• Registration Number: NCT02083783
• Lead Sponsor: Tris Pharma, Inc.

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-11
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Disposition First Submitted: 2015-05-07
• Disposition First Submitted QC: 2015-05-22
• Disposition First Posted: 2015-06-15
• Results First Submitted: 2019-05-15
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-24
• Last Update Submitted: 2020-08-24
• Results First Posted: 2020-08-26
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
TRI102	TRI102	Active, amphetamine extended-release oral suspension

Primary Outcome Measures

Name	Time	Method
SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale)	Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose	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.

Secondary Outcome Measures

Name	Time	Method
PERMP (Permanent Product Measure of Performance).	Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose.	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.

Trial Locations

Locations (5)

Bayou City Research; 🇺🇸 Houston, Texas, United States

Westex Clinical Investigation; 🇺🇸 Lubbock, Texas, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Newport Beach Clinical Research Associates, Inc.; 🇺🇸 Newport Beach, California, United States

Center for Psychiatry and Behavioral Medicine, Inc.; 🇺🇸 Las Vegas, Nevada, United States