Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00224952
Other study ID # PPRU 10606
Secondary ID NIH Grant HD0442
Status Completed
Phase N/A
First received September 21, 2005
Last updated August 11, 2017
Start date July 2002
Est. completion date March 2010

Study information

Verified date August 2017
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 274
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender All
Age group 1 Year to 16 Years
Eligibility 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:

Study Design


Related Conditions & MeSH terms

  • Drug-Related Side Effects and Adverse Reactions
  • Seizures

Intervention

Other:
No intervention; Urine Collection
Urine collected from children receiving carbamazepine or valproic acid as part of their clinical management

Locations

Country Name City State
United States Children's Mercy Hospital Kansas City Missouri
United States Kosair Children's Hospital Louisville Kentucky
United States Primary Children's Hospital, Pediatric Neurology Salt Lake City Utah

Sponsors (4)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Louisville, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug (Valproic Acid or Carbamazepine) Metabolite Profiles in Urine 1. To examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine the identities of the reactive metabolites or, alternatively, the identities of those metabolites that serve as potential precursors to reactive species (e.g., through conjugation with detoxifying compounds such as glutathione). urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years
Secondary Age-related Changes in Bioactivation 2. To determine if age-related differences exist regarding the ability of pediatric patients to bioactivate carbamazepine or valproate to reactive metabolites. Data provided below reflect the slope of the least squares regression. urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years
See also
  Status Clinical Trial Phase
Recruiting NCT02850913 - Doxycycline for the Treatment of Nodding Syndrome Phase 2
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Not yet recruiting NCT06045676 - Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital
Completed NCT03722212 - Early Diagnosis of the GLUT1 Deficiency Syndrome With a Blood Based Test N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Completed NCT02897856 - Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures Phase 4
Completed NCT01239212 - Dosing of Levetiracetam (Keppra) in Neonates Phase 1/Phase 2
Completed NCT01236001 - Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older N/A
Completed NCT01703468 - Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions Phase 1
Completed NCT01702623 - Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions Phase 1
Recruiting NCT02216500 - Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy N/A
Completed NCT00236717 - A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy Phase 3
Terminated NCT03954314 - DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery Phase 3
Completed NCT05103735 - Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Terminated NCT03790436 - Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet N/A
Completed NCT06451289 - Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures
Recruiting NCT02552511 - Epidemiology Study on Neonatal Seizure
Recruiting NCT05339126 - RNS System LGS Feasibility Study Phase 2
Active, not recruiting NCT04595786 - The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection N/A
Recruiting NCT04770337 - Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy N/A