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Completed

NCT Number: NCT00050934

Pediatric Epilepsy Study

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.

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Key information

Conditions

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

Age range

1 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brigadeiro Hospital, Sao Paulo - SP, Brazil

Loading trial locations.

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
  • 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

Treatment and study plan

Oxcarbazepine

Drug

Primary outcomes

  1. change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)

Secondary outcomes

  1. % 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).

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 Adjunctive Therapy 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.

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