Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299234
Status:
TERMINATED
Last Update Posted:
2012-04-26
First Post:
2006-03-02
Brief Title:
Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for ALL
Sponsor:
Monarch Medical Research
Organization:
Monarch Medical Research
Study Overview
Official Title:
Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient number of interested potentital subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a double-blind placebo-controlled parallel group trial of atomoxetine 18 mgkg 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-DeficitHyperactivity 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 18mgkg 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
The secondary objectives are
1 to assess the effect of once daily AM dosing of atomoxetine 18mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None