NCT00299234

Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for ALL

Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Monarch Medical Research · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a double-blind, placebo-controlled, parallel group trial of atomoxetine (1.8 mg/kg) for the management of chemotherapy-related acquired attentional disorders in children who have survived Acute Lymphocytic Leukemia. Atomoxetine will produce a favorable impact on ADHD symptoms in children with chemo-related acquired attentional disorders.

Detailed description

The primary objective of this study is to assess the safety, tolerability and efficacy of atomoxetine as determined by the change in the ADHD-RS-IV Total score compared to placebo in the symptomatic treatment of patients diagnosed with Attention-Deficit/Hyperactivity Disorder (by DSM-IV ADHD-NOS criteria) occurring as a neuropsychological late-effect of chemotherapy used to treat Acute Lymphocytic Leukemia (ALL). The secondary objectives are: 1. to assess the effect of once daily (AM) dosing of atomoxetine (1.8mg/kg) compared to placebo on ADHD symptoms as measured by: * ADHD-RS Total score inclusive of subtypes for inattention, hyperactivity and combined subtypes. * Clinical Global Impression-ADHD 2. to evaluate the safety and tolerability of atomoxetine compared with placebo based on treatment-emergent adverse events (AEs), laboratory tests, vital signs, physical examinations, and ECGs.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Atomoxetine	titration schedule: 0.5 to 1.5 mg/kg/day

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-03-06
• Last updated: 2012-04-26

Locations

1 site across 1 country: United States