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

Tris Pharma

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: TRI102; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02083783

TRI102-ADD-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

108 participants in 2 patient groups, including a placebo group

TRI102

Experimental group

Description:

Active, amphetamine extended-release oral suspension

Treatment:

Drug: TRI102

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo