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

This study has been terminated.
(Insufficient number of interested potentital subjects)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Monarch Medical Research
ClinicalTrials.gov Identifier:
NCT00299234
First received: March 2, 2006
Last updated: April 25, 2012
Last verified: April 2007
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Atomoxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Monarch Medical Research:

Primary Outcome Measures:
  • The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome is the difference in CGI categories by the treatment versus placebo group. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
placebo
Drug: Atomoxetine
titration schedule: 0.5 to 1.5 mg/kg/day
Experimental: 1
atomoxetine
Drug: Atomoxetine
titration schedule: 0.5 to 1.5 mg/kg/day

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.
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299234

Locations
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
Investigators
Principal Investigator: Donald W Lewis, MD Monarch Medical Research
  More Information

Publications:
Responsible Party: Donald W Lewis, MD, Children's Specialty Group
ClinicalTrials.gov Identifier: NCT00299234     History of Changes
Other Study ID Numbers: B4Z-MC-X040
Study First Received: March 2, 2006
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Monarch Medical Research:
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Atomoxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014