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Pediatric Epilepsy Study

Primary Purpose

Epilepsy, Epilepsies, Partial

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 - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigadeiro Hospital
  • Novartis

Outcomes

Primary Outcome Measures

change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)

Secondary Outcome Measures

% 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).

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
NCT00050934
Brief Title
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

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 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 add-on therapy 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, Epilepsies, Partial
Keywords
partial seizures

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oxcarbazepine
Primary Outcome Measure Information:
Title
change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)
Secondary Outcome Measure Information:
Title
% 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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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
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
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
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
Wilmington
State/Province
Delaware
ZIP/Postal Code
19806
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
Boise
State/Province
Idaho
ZIP/Postal Code
83712
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
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
New York
State/Province
New York
ZIP/Postal Code
10032
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
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Brigadeiro Hospital
City
Sao Paulo - SP
ZIP/Postal Code
01401-901
Country
Brazil
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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