drugset / Trial / NCT00528697

A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00528697 ↗

Phase 2 Completed 278 enrolled AbbVie
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.

Timeline

Start
2007-09
Primary completion
2008-04
Completion
2008-04

Outcome

Missed primary endpoint

paper ABT-089 did not show efficacy on the primary efficacy variable, the ADHD-RS-IV (HV) Total Score, or other measures of ADHD symptomatology PMID 21156272 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atomoxetine Other / unclassified 10 mg —
Comparator Atomoxetine Other / unclassified 18 mg —
Comparator Atomoxetine Other / unclassified 25 mg —
Subject Pozanicline Small molecule 0.5 mg —
Subject Pozanicline Small molecule 1 mg —
Subject Pozanicline Small molecule 5 mg —
Subject Pozanicline Small molecule 10 mg —