Status:
TERMINATED
Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for ALL
Lead Sponsor:
Monarch Medical Research
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
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 survive...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00299234
Start Date
June 1 2006
End Date
December 1 2007
Last Update
April 26 2012
Active Locations (1)
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1
Monarch Medical Research - Child and Adolescent Neurology
Norfolk, Virginia, United States, 23510