Pediatric Epilepsy Study

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

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Key information

Conditions

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

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brigadeiro Hospital, Sao Paulo - SP, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To enter this study, patients must:

Have a diagnosis of partial seizures
Have 2-30 seizures per week while on a stable dose of one anti-epileptic drug or be a patient recently diagnosed with partial seizures and currently receiving no seizure medication
Be willing to be hospitalized for up to 5 days
Weigh a minimum of 6.6 lbs
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
This study has some AED restrictions
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
A history of substance abuse (including alcohol)
Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds
Used experimental medication within 30 days of entering this study

Treatment and study plan

Oxcarbazepine

Drug

Primary outcomes

Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.

Secondary outcomes

Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: Jan 1, 2003
Registry last updated: Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed