Pediatric Epilepsy Study

This study has been completed.

First Received on December 30, 2002. Last Updated on November 22, 2011 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00050934

Purpose

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.

Condition	Intervention	Phase
Epilepsy Epilepsies, Partial	Drug: oxcarbazepine	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Oxcarbazepine

U.S. FDA Resources

Further study details as provided by Novartis:

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).

Enrollment:	132
Study Start Date:	June 2002
Study Completion Date:	June 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	1 Month to 3 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050934

Show 30 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00050934 History of Changes
Other Study ID Numbers:	CTRI476E 2340
Study First Received:	December 30, 2002
Last Updated:	November 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

partial seizures

Additional relevant MeSH terms:

Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Oxcarbazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012