Expired Study
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Tampa, Florida 33607


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.


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


Study is Available At:


Original ID:

CTRI476E 2340


NCT ID:

NCT00050934


Secondary ID:


Study Acronym:


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.


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

1 Month


Maximum Age:

3 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, P


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

132


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:June 2002
Completion Date:June 2004
Completion Type:Actual
Primary Completion Date:June 2004
Primary Completion Type:Actual
Verification Date:November 2011
Last Changed Date:November 22, 2011
First Received Date:December 30, 2002

Study Outcomes

Outcome Type:Secondary Outcome
Measure:% 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).
Safety Issues:False
Outcome Type:Primary Outcome
Measure:change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:oxcarbazepine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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