|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Collaborators: |
University of Utah University of Louisville |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00224952 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Seizures |
Other: No intervention; Urine Collection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | The Role of Drug Metabolizing Enzymes in the Pathogenesis Adverse Drug Reactions in Children |
Urine DNA (source: blood or saliva)
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2002 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 1 |
Other: No intervention; Urine Collection
Urine collected from children receiving carbamazepine or valproic acid as part of their clinical management
Other Names:
|
| 2 |
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 that are dose-dependent and largely predictable from the known pharmacologic properties of the compound in question, and those that are dependent on characteristics unique to susceptible individuals, or idiosyncratic in nature.
The long term objective of this research is to characterize the mechanisms responsible for the pathogenesis of idiosyncratic hypersensitivity reactions in children, particularly those involving carbamazepine and other aromatic anticonvulsants.
The study is divided into two phases. Phase 1 of the study involves collecting urine from 50 patients taking CBZ therapeutically. Participants will be asked to provide a spot urine sample during routine health visits. The urine will be analyzed for the presence of CBZ and its metabolites. In Phase 2 of the study, urine will be collected from patients taking either CBZ or VPA therapeutically. If blood samples are drawn from these patients for medical purposes not related to this study the residual blood sample will be recovered before it is discarded for use in genotyping analysis. Participants will be asked to provide a urine sample covering one complete dosing interval of CBZ or VPA (preferably overnight). Patients will also be followed longitudinally, with urine collections at each clinic visit over at least a two year period.
Eligibility| Ages Eligible for Study: | 1 Year to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Pediatric patients of both genders between 1 and 16 years of age receiving carbamazepine (CBZ) or valproic acid (VPA) as monotherapy or polytherapy
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kentucky | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Utah | |
| Primary Children's Hospital, Pediatric Neurology | |
| Salt Lake City, Utah, United States, 84113 | |
| Principal Investigator: | J. Steven Leeder, Pharm.D., Ph.D., | Children's Mercy Hospital |
More Information
| Responsible Party: | LEEDER, James Steven, Children's Mercy Hospitals and Clinics |
| ClinicalTrials.gov Identifier: | NCT00224952 History of Changes |
| Other Study ID Numbers: | PPRU 10606, NIH Grant HD044239 |
| Study First Received: | September 21, 2005 |
| Last Updated: | December 15, 2008 |
| Health Authority: | United States: Federal Government |
|
seizures Epilepsy |
|
Seizures Drug Toxicity Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Poisoning Substance-Related Disorders Valproic Acid Carbamazepine Anticonvulsants Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |