NCT00299234

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2007

Enrollment Period

1.5 years

First QC Date

March 2, 2006

Last Update Submit

April 25, 2012

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

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

    5 weeks

Secondary Outcomes (1)

  • The secondary outcome is the difference in CGI categories by the treatment versus placebo group.

    5 weeks

Study Arms (2)

2

PLACEBO COMPARATOR

placebo

Drug: Atomoxetine

1

EXPERIMENTAL

atomoxetine

Drug: Atomoxetine

Interventions

AtomoxetineDRUG

titration schedule: 0.5 to 1.5 mg/kg/day

12

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monarch Medical Research - Child and Adolescent Neurology

Norfolk, Virginia, 23510, United States

Location

Related Publications (3)

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

    PMID: 3056531BACKGROUND

  • Schuler D, Bakos M, Borsi J, Gacsaly I, Kalmanchey R, Kardos G, Koos R, Nagy C, Revesz T, Somlo P, et al. Neuropsychologic and CT examinations in leukemic patients surviving 10 or more years. Med Pediatr Oncol. 1990;18(2):123-5. doi: 10.1002/mpo.2950180207.

    PMID: 2304419BACKGROUND

  • 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.

    PMID: 6941969BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Donald W Lewis, MD

    Monarch Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2006

First Posted

March 6, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 26, 2012

Record last verified: 2007-04

Locations

US(1)