Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255138
Recruitment Status : Withdrawn
First Posted : November 17, 2005
Last Update Posted : October 31, 2008
Eli Lilly and Company
Information provided by:
Temple University

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Cognitive Late Effects Drug: Atomoxetine Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers
Study Start Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Conner's Parent Rating Scale (CPRS)

Secondary Outcome Measures :
  1. Conner's Teacher Rating Scale (CTRS)
  2. Continuous Performance Test (CPT)
  3. Side Effects Rating Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255138

United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Eli Lilly and Company
Principal Investigator: Ronald T Brown, Ph.D. Temple University Identifier: NCT00255138     History of Changes
Other Study ID Numbers: 4463
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: October 31, 2008
Last Verified: October 2008

Keywords provided by Temple University:
Cognitive Late Effects

Additional relevant MeSH terms:
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs