Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia
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
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.
Donald W Lewis, MD
Monarch Medical Research
United States: Institutional Review Board
|Monarch Medical Research - Child and Adolescent Neurology||Norfolk, Virginia 23510|