Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166686
Status:
WITHDRAWN
Last Update Posted:
2013-01-11
First Post:
2005-09-09
Brief Title:
Clonidine for Neurocognitive Sequelae
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Clonidine for the Treatment of Neurocognitive Sequelae Following Cancer Treatment in Children
Status:
WITHDRAWN
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was never initiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens academic and psychosocial function
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None