Pediatric Epilepsy Study
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.
1 other identifier
interventional
94
4 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2002
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 30, 2002
CompletedFirst Posted
Study publicly available on registry
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedNovember 23, 2011
November 1, 2011
1.6 years
December 30, 2002
November 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.
Secondary Outcomes (1)
Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Birmingham, Alabama, 35233, United States
Unknown Facility
Mobile, Alabama, 36693, United States
Unknown Facility
Madera, California, 93638, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Miami, Florida, 33155, United States
Unknown Facility
Tampa, Florida, 33607, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Duluth, Minnesota, 55805, United States
Unknown Facility
Saint Paul, Minnesota, 55102, United States
Unknown Facility
Chesterfields, Missouri, 63017, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Buffalo, New York, 14222, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Raleigh, North Carolina, 27607, United States
Unknown Facility
Akron, Ohio, 44308, United States
Unknown Facility
Cincinnati, Ohio, 45229, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Portland, Oregon, 97201, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Spartenberg, South Carolina, 29303, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
Houston, Texas, 77030, United States
Brigadeiro Hospital
Sao Paulo - SP, 01401-901, Brazil
Unknown Facility
Jena, 07740, Germany
Unknown Facility
Kehl-Kork, 77694, Germany
Unknown Facility
Kiel, 24105, Germany
Novartis
Mexico City, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2002
First Posted
January 1, 2003
Study Start
July 1, 2002
Primary Completion
February 1, 2004
Study Completion
February 1, 2004
Last Updated
November 23, 2011
Record last verified: 2011-11