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Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00255138
First Posted: November 17, 2005
Last Update Posted: October 31, 2008
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.
Collaborator:
Eli Lilly and Company
Information provided by:
Temple University
November 15, 2005
November 17, 2005
October 31, 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
Intervention Model: Crossover Assignment
Masking: Double
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
Sexes Eligible for Study: All
6 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00255138
4463
Not Provided
Not Provided
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