N/A
N=274
Pathogenesis of Adverse Drug Reactions
Seizures
Bottom Line
View on ClinicalTrials.gov: NCT00224952 ↗Enrolled (actual)
274
Serious AEs
—
Results posted
Aug 2017
Primary outcome: Primary: Drug (Valproic Acid or Carbamazepine) Metabolite Profiles in Urine — 15.2; 13.1; 1.15; 2.13 nmol per mg creatinine
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention; Urine Collection (Other)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug (Valproic Acid or Carbamazepine) Metabolite Profiles in Urine |
15.2; 13.1; 1.15; 2.13; 5.88 | — |
| SECONDARY Age-related Changes in Bioactivation |
-0.8876; -0.0244; -0.00033; -00122; -0.0295; -0.0250 | 0.004 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00224952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.