Pathogenesis of Adverse Drug Reactions

NCT00224952 | Completed Results

• 2 other identifiers: PPRU 10606NIH Grant HD044239
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 3

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

Conditions

Seizures

Keywords

seizures; Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Age-related Changes in Bioactivation

  urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years

Study Arms (1)

Patients receiving Carbamazepine or Valproic Acid

Other: No intervention; Urine Collection

Interventions

No intervention; Urine Collection OTHER

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

Also known as: carbamazepine: Tegretol, valproic acid: Depakote

Patients receiving Carbamazepine or Valproic Acid

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients of both genders between 1 and 16 years of age receiving carbamazepine (CBZ) or valproic acid (VPA) as monotherapy or polytherapy

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Utah: collaborator
• University of Louisville: collaborator

Study Sites (3)

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Primary Children's Hospital, Pediatric Neurology

Salt Lake City, Utah, 84113, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine DNA (source: blood or saliva)

MeSH Terms

Conditions

Seizures; Epilepsy

Interventions

Urine Specimen Collection; Carbamazepine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: J. Steven Leeder Pharm D, PhD
• Organization: The Children's Mercy Hospital

sleeder@cmh.edu

816-234-3059

Study Officials

• J. Steven Leeder, Pharm.D., Ph.D.,

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm.D; Ph.D

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: July 1, 2002
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 14, 2017
• Results First Posted: August 14, 2017

Record last verified: 2017-08

Locations

US (3)