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

Stopped early · Phase 4

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT00299234

Run by

Monarch Medical Research

People needed

1

Starts

2006-06-01

Expected to finish

2007-12-01

Last updated by the study team

2012-04-26

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Monarch Medical Research - Child and Adolescent Neurology — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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