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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This study has been withdrawn prior to enrollment.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

November 15, 2005
October 28, 2008
November 2005
Not Provided
Conner's Parent Rating Scale (CPRS)
Same as current
Complete list of historical versions of study NCT00255138 on ClinicalTrials.gov Archive Site
  • Conner's Teacher Rating Scale (CTRS)
  • Continuous Performance Test (CPT)
  • Side Effects Rating Scale
Same as current
Not Provided
Not Provided
 
Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects
Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Cancer
  • Cognitive Late Effects
Drug: Atomoxetine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
60
Not Provided
Not Provided

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
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00255138
4463
Not Provided
Not Provided
Temple University
Eli Lilly and Company
Principal Investigator: Ronald T Brown, Ph.D. Temple University
Temple University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP