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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00299234
Recruitment Status : Terminated (Insufficient number of interested potentital subjects)
First Posted : March 6, 2006
Last Update Posted : April 26, 2012
Eli Lilly and Company
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Atomoxetine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia
Study Start Date : June 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Placebo Comparator: 2
Drug: Atomoxetine
titration schedule: 0.5 to 1.5 mg/kg/day

Experimental: 1
Drug: Atomoxetine
titration schedule: 0.5 to 1.5 mg/kg/day

Primary Outcome Measures :
  1. The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study. [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. The secondary outcome is the difference in CGI categories by the treatment versus placebo group. [ Time Frame: 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00299234

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United States, Virginia
Monarch Medical Research - Child and Adolescent Neurology
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Monarch Medical Research
Eli Lilly and Company
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Principal Investigator: Donald W Lewis, MD Monarch Medical Research

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Responsible Party: Donald W Lewis, MD, Children's Specialty Group Identifier: NCT00299234     History of Changes
Other Study ID Numbers: B4Z-MC-X040
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2007

Keywords provided by Monarch Medical Research:
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs