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

Phase 4

Terminated

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Atomoxetine

• Registration Number: NCT00299234
• Lead Sponsor: Monarch Medical Research

Brief 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.

Study Timeline

• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-02
• Study First Posted: 2006-03-06
• Study Start: 2006-06
• Status Verified: 2007-04
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2012-04-25
• Last Update Posted: 2012-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Ages 6-18 years
• Must have successfully completed treatment for ALL and are currently 1-year "disease free" as judged by the investigators.
• Must meet DSM-IV criteria for "ADHD-NOS.( Attachment A) The attention deficit symptoms have been precipitated by chemotherapy-related neurological injury. Therefore, the DSM-IV category is ADHD-NOS.
• Must have an Investigator-completed ADHD-RS total and/or subscale score of ≥1.5 standard deviations above age/gender norm.
• Laboratory results, including chemistries, hematology, and urinalysis do not demonstrate clinically significant abnormalities.
• ECG demonstrates no clinically significant abnormalities
• Educational level and degree of understanding of the patient and their parents permit suitable communication between the investigators and study coordinators.
• Subjects and parents are judged to be reliable to keep appointments.
• Must be able to swallow tablets.
• Must have demonstrated compliance during their chemotherapy program.
• Must weigh > 20 kg.

Exclusion Criteria

• Have relapsed or are having re-occurring symptoms/signs of ALL.
• Have had substantial exposure to radiation therapy (>2000: cGy) since high dose radiation treatment is associated with neurocognitive deficits or be "treatment resistant" pharmacologically.
• Past exposure to atomoxetine.
• ADHD symptoms or treatment prior to the diagnosis of ALL
• Documented bipolar disorder, psychosis, affective disorder.
• Female subjects who are pregnant or breastfeeding.
• Suicide risk.
• Seizure disorders (except history of febrile seizures).
• Histories of multiple drug allergies.
• Histories of alcohol or substance abuse.
• Prior or current medical conditions that, in the opinion of the investigators, could be exacerbated by atomoxetine.
• Sympathomimetic overactivity such as catecholamine secreting tumor.
• Use of MAOI medications.
• Have taken psychostimulants one week prior to randomization.
• Current or past history of hypertension.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Atomoxetine	atomoxetine
2	Atomoxetine	placebo

Primary Outcome Measures

Name	Time	Method
The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.	5 weeks

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is the difference in CGI categories by the treatment versus placebo group.	5 weeks

Trial Locations

Locations (1)

Monarch Medical Research - Child and Adolescent Neurology; 🇺🇸 Norfolk, Virginia, United States