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

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Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Atomoxetine

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Monarch Medical Research - Child and Adolescent Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

placebo

atomoxetine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00299234

First Posted

March 2, 2006

Last Updated

April 25, 2012

Sponsor

Monarch Medical Research

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00299234

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Terminated

Why Stopped

Insufficient number of interested potentital subjects

Study Start Date

June 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Monarch Medical Research

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2

Arm Type

Placebo Comparator

Arm Description

placebo

Arm Title

1

Arm Type

Experimental

Arm Description

atomoxetine

Intervention Type

Drug

Intervention Name(s)

Atomoxetine

Intervention Description

titration schedule: 0.5 to 1.5 mg/kg/day

Primary Outcome Measure Information:

Title

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

Time Frame

5 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald W Lewis, MD

Organizational Affiliation

Monarch Medical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Monarch Medical Research - Child and Adolescent Neurology

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

3056531

Citation

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

Results Reference

background

PubMed Identifier

2304419

Citation

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.

Results Reference

background

PubMed Identifier

6941969

Citation

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.

Results Reference

background

Attention Deficit Hyperactivity Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial