Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for ALL
| Status: | Archived |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia
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.
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.
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