Atomoxetine for Children With Acquired Attentional Disord... | NCT00299234

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

NCT00299234

Sponsor

Monarch Medical Research

Status

Terminated

Last Update Posted

Apr 26, 2012Estimated

Enrollment

1Actual

Phase

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Atomoxetine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient number of interested potentital subjects

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Mar 2, 2006

First Submission Date that Met QC Criteria

Mar 2, 2006

First Posted Date

Mar 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2012

Last Update Posted Date

Apr 26, 2012Estimated

Name	Class
Eli Lilly and Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

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
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
2	Placebo Comparator	placebo	Drug: Atomoxetine
1	Experimental	atomoxetine	Drug: Atomoxetine

Name	Type	Description	Arm Group Labels	Other Names
Atomoxetine	Drug	titration schedule: 0.5 to 1.5 mg/kg/day	1 2

Measure	Description	Time Frame
The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.		5 weeks

Measure	Description	Time Frame
The secondary outcome is the difference in CGI categories by the treatment versus placebo group.		5 weeks

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Donald W Lewis, MD	Monarch Medical Research	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Monarch Medical Research - Child and Adolescent Neurology		Norfolk	Virginia	23510	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3056531	Background	Mulhern RK, Friedman AG, Stone PA. Acute lymphoblastic leukemia: long-term psychological outcome. Biomed Pharmacother. 1988;42(4):243-6.
2304419	Background	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.

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals