CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 274 enrolled
Drug / intervention
No intervention; Urine Collectionother
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Pediatric patients aged 1–16 years receiving carbamazepine or valproic acid monotherapy
  • ✓Patients on other seizure medications who subsequently add carbamazepine or valproic acid
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00224952
NCT00224952N/ACompleted
CompareCT.gov

The Role of Drug Metabolizing Enzymes in the Pathogenesis Adverse Drug Reactions in Children

Children's Mercy Hospital Kansas City·observational·Posted Sep 23, 2005·Updated Aug 14, 2017

In Brief

An observational study evaluating No intervention; Urine Collection for Seizures. Completed, enrolled 274 participants across 3 sites.

Detailed 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 metabolites or, alternatively, the identities of those metabolites that serve as potential precursors to reactive species.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSeizures
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Utah, University of Louisville

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 23, 2005
Enrollment StartJul 1, 2002
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 20.8 years ago

Interventions

No intervention; Urine Collectionother

Urine collected from children receiving carbamazepine or valproic acid as part of their clinical management