Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects - Full Text View

Sponsors and Collaborators:	Temple University Eli Lilly and Company
Information provided by:	Temple University
ClinicalTrials.gov Identifier:	NCT00255138

Purpose

The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.

Condition	Intervention	Phase
Cancer Cognitive Late Effects	Drug: Atomoxetine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Further study details as provided by Temple University:

Primary Outcome Measures:

Conner's Parent Rating Scale (CPRS)

Secondary Outcome Measures:

Conner's Teacher Rating Scale (CTRS)
Continuous Performance Test (CPT)
Side Effects Rating Scale

Estimated Enrollment:	60
Study Start Date:	November 2005

Detailed Description:

In previous years, it had often been assumed that cognitive and behavioral declines in children who survived cancer therapy were largely a function of the prophylactic therapies (e.g., radiation, chemotherapy) that these children had received. Regardless of the etiologies of these specific late effects, the data regarding the long-term outcome of these children are strikingly consistent. Generally, the studies to date suggest significant impairments in attention and concentration that result in marked declines in academic performance and social and behavior difficulties.

Despite the clear evidence of problems with attention and concentration, as well as associated fucntional impairments (e.g., poor academic achievement and poor peer relationships), there have been few clinical trials designed to manage the cogntive late effects and neurological toxicities associated with radiation therapy and chemotherapy for children and adolescents who have survived cancer.

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 6-18
Patient has received chemotherapy, radiation, or a combination of both.
Patient is at least 12 months post-competion of therapy but no more than five years post-completion of therapy.

Exclusion Criteria:

No ongoing pharmacological management of ADHD
Not currently pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255138

Locations

United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

Temple University

Eli Lilly and Company

Investigators

Principal Investigator:

Ronald T Brown, Ph.D.

Temple University

More Information

No publications provided

Study ID Numbers:	4463
Study First Received:	November 15, 2005
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00255138 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Temple University:

Cancer
Cognitive Late Effects
Stimulants

Atomoxetine
Attention
Children

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Atomoxetine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Atomoxetine
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009