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

Phase 4
6 Years
18 Years
Not Enrolling
Attention Deficit Hyperactivity Disorder

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Trial Information

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
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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.

Outcome Time Frame:

5 weeks

Safety Issue:


Principal Investigator

Donald W Lewis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Monarch Medical Research


United States: Institutional Review Board

Study ID:




Start Date:

June 2006

Completion Date:

December 2007

Related Keywords:

  • Attention Deficit Hyperactivity Disorder
  • Attention Deficit Hyperactivity Disorder
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Attention Deficit Disorder with Hyperactivity
  • Hyperkinesis



Monarch Medical Research - Child and Adolescent Neurology Norfolk, Virginia  23510