Clinical Trial: Clonidine for Neurocognitive Sequelae

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Clonidine for the Treatment of Neurocognitive Sequelae Following Cancer Treatment in Children

Brief Summary: The goals of the study are to determine the efficacy of clonidine in the treatment of children with neurocognitive sequelae following the therapy of long term malignancies. In addition, the study hopes to determine the long-term effect of clonidine on children's academic and psychosocial function.

Detailed Summary:

The long term prognosis for many children diagnosed with brain tumors and other malignancies has improved dramatically over the last decades and is expected to continue to rise as a result of improved treatment. The increased survival in pediatric oncology, however, has been associated with an increased recognition of neurobehavioral sequelae of cancer and its treatment. Current understanding of the incidence, pathogenesis, and natural history of these neurobehavioral abnormalities is limited and considerable individual variation in the presence and severity of these complications has been noted. Central nervous system (CNS) abnormalities associated with childhood cancer and its treatment have been demonstrated on at least three levels which may be interrelated: neurobehavioral abnormalities, brain imaging abnormalities, and neurotransmitter abnormalities.

Patients will be randomized to either clonidine or placebo. Study medication will be administered in a double blind fashion beginning with a four-week dose titration period followed by a four-week maintenance period. Total duration of dosing is 18 weeks. Patients who derive a benefit from clonidine administration may continue for an additional 30 weeks of therapy. PK samples will be collected at weeks 9 and 18.

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Dates:
Date Received: September 9, 2005
Date Started:
Date Completion:
Last Updated: January 10, 2013
Last Verified: January 2013