Clinical trial NCT00050934: Pediatric Epilepsy Study
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Epilepsies, Partial
Keywords: partial seizures
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2003-01-01
Enrollment: 132
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)
Secondary outcomes:
measure: % 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).
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Madera
country: United States
state: California
city: Orange
country: United States
state: California
city: Wilmington
country: United States
state: Delaware
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Ann Arbor
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
city: Chesterfields
country: United States
state: Missouri
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Sao Paulo - SP
country: Brazil
facility: Brigadeiro Hospital
city: Kehl-Kork
country: Germany
city: Kiel
country: Germany
city: Mexico City
country: Mexico
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: