Pediatric Epilepsy Study

Epilepsy Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050934
• Other study ID #: CTRI476E 2340
• Status: Completed
• Phase: Phase 3
• First received: December 30, 2002
• Last updated: November 22, 2011
• Start date: June 2002
• Est. completion date: June 2004

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 3 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

Drug:
• oxcarbazepine

Locations

Country	Name	City	State
Brazil	Brigadeiro Hospital	Sao Paulo - SP
Mexico	Novartis	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Brazil,  Germany,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)
Secondary	% 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).