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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00299234
• Other study ID #: B4Z-MC-X040
• Status: Terminated
• Phase: Phase 4
• First received: March 2, 2006
• Last updated: April 25, 2012
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2007
• Source: Monarch Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
United States	Monarch Medical Research - Child and Adolescent Neurology	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Monarch Medical Research	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (3)

Goff JR, Anderson HR Jr, Cooper PF. Distractibility and memory deficits in long-term survivors of acute lymphoblastic leukemia. J Dev Behav Pediatr. 1980 Dec;1(4):158-63. — View Citation

Mulhern RK, Friedman AG, Stone PA. Acute lymphoblastic leukemia: long-term psychological outcome. Biomed Pharmacother. 1988;42(4):243-6. Review. — View Citation

Schuler D, Bakos M, Borsi J, Gacsály I, Kálmánchey R, Kardos G, Koós R, Nagy C, Révész T, Somló P, et al. Neuropsychologic and CT examinations in leukemic patients surviving 10 or more years. Med Pediatr Oncol. 1990;18(2):123-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.		5 weeks	No
Secondary	The secondary outcome is the difference in CGI categories by the treatment versus placebo group.		5 weeks	No