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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083783
• Other study ID #: TRI102-ADD-001
• Status: Completed
• Phase: Phase 3
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2020
• Source: Tris Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• TRI102
formulation containing active moiety (amphetamine)

Other:
• Placebo
formulation without active moiety

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Bayou City Research	Houston	Texas
United States	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada
United States	Westex Clinical Investigation	Lubbock	Texas
United States	Newport Beach Clinical Research Associates, Inc.	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Tris Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.