Clinical trial NCT00050947: Pediatric Epilepsy Study
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: partial seizures
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2003-01-01
Enrollment: 94
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.
Secondary outcomes:
measure: Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Madera
country: United States
state: California
city: Orange
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
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: St. Louis
country: United States
state: Missouri
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
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: Pittsburgh
country: United States
state: Pennsylvania
city: Spartenberg
country: United States
state: South Carolina
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Sao Paulo - SP
country: Brazil
facility: Brigadeiro Hospital
city: Jena
country: Germany
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: