Status:
COMPLETED
Pathogenesis of Adverse Drug Reactions
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Utah
Conditions:
Seizures
Eligibility:
All Genders
1-16 years
Brief Summary
The purpose of the study is to examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine identities of the reactive metab...
Detailed Description
Adverse drug reactions can be broadly defined as any undesirable response associated with therapeutic drug use. A simple and clinically useful classification is to divide adverse events into those tha...
Eligibility Criteria
Inclusion
- Pediatric patients of both genders between 1 and 16 years of age receiving CBZ or VPA mono-therapy will be recruited for this study. Additionally, for those patients who are receiving drugs other than CBZ or VPA to control their seizures, if CBZ or VPA are subsequently added to their treatment regimen, then these patients will also be recruited for this study.
Exclusion
- None
Key Trial Info
Start Date :
July 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00224952
Start Date
July 1 2002
End Date
March 1 2010
Last Update
August 14 2017
Active Locations (3)
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1
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
3
Primary Children's Hospital, Pediatric Neurology
Salt Lake City, Utah, United States, 84113