Pediatric Epilepsy Study

A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Adjunctive Therapy in Pediatric Patients With Inadequately-controlled Partial Seizures.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00050934

Enrollment

132

Registered

2003-01-01

Start date

2002-06-30

Completion date

2004-06-30

Last updated

2011-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsies, Partial, Epilepsy

Keywords

partial seizures

Brief summary

This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.

Interventions

DRUGoxcarbazepine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

1 Months to 3 Years

Healthy volunteers

Inclusion criteria

To enter this study, patients must: * Have a diagnosis of partial seizures * Be willing to be hospitalized * Weigh a minimum of 6.6 pounds * Be taking a stable dose of one to two concomitant anti-epileptic medications * Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease * Have normal laboratory results

Exclusion criteria

To enter this study, a patient must not have or be: * Seizures caused by metabolic disturbance, toxic exposure, or active infection * A primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures) * A history of status epilepticus within 30 days * Seizures not related to epilepsy * Frequent use of additional anti-epileptic medications to treat increases in seizures (for example: rectal diazepam) * Taking felbamate within 6 months * Serum sodium levels \<135 mEq/L * Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy * A history of chronic infection (e.g., hepatitis or HIV) * Significant electrocardiogram (ECG) abnormalities * A nursing mother taking anti-convulsant drugs * Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds * Used experimental medication within 30 days of entering this study

Design outcomes

Primary

Measure	Time frame
change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)	—

Secondary

Measure	Time frame
% change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours).	—

Countries

Brazil, Germany, Mexico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026