Pediatric Epilepsy Study - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
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 III

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

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).

Estimated Enrollment:	128
Study Start Date:	October 2002
Study Completion Date:	June 2004

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 32 Study Locations

Sponsors and Collaborators

Novartis

More Information

No publications provided

Study ID Numbers:	CTRI476E 2340
Study First Received:	December 30, 2002
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00050934 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

partial seizures

Additional relevant MeSH terms:

Epilepsies, Partial
Oxcarbazepine
Epilepsy
Therapeutic Uses
Nervous System Diseases

Central Nervous System Diseases
Brain Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010