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Pediatric Epilepsy Study

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
oxcarbazepine
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring partial seizures

Eligibility Criteria

1 Month - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigadeiro Hospital
  • Novartis

Outcomes

Primary Outcome Measures

Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.

Secondary Outcome Measures

Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase

Full Information

First Posted
December 30, 2002
Last Updated
November 22, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00050947
Brief Title
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

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
partial seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oxcarbazepine
Primary Outcome Measure Information:
Title
Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.
Secondary Outcome Measure Information:
Title
Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
City
Madera
State/Province
California
ZIP/Postal Code
93638
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
City
Chesterfields
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Spartenberg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Brigadeiro Hospital
City
Sao Paulo - SP
ZIP/Postal Code
01401-901
Country
Brazil
City
Jena
ZIP/Postal Code
07740
Country
Germany
City
Kehl-Kork
ZIP/Postal Code
77694
Country
Germany
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Novartis
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

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Pediatric Epilepsy Study

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