Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00255138
First received: November 15, 2005
Last updated: October 28, 2008
Last verified: October 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Temple University:
Cancer
Cognitive Late Effects
Stimulants
Atomoxetine
Attention
Children

Additional relevant MeSH terms:
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014