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Pediatric Epilepsy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00050934
First received: December 30, 2002
Last updated: November 22, 2011
Last verified: November 2011
History of Changes

December 30, 2002
November 22, 2011
June 2002
June 2004   (final data collection date for primary outcome measure)
change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)
Not Provided
Complete list of historical versions of study NCT00050934 on ClinicalTrials.gov Archive Site
% 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).
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Pediatric Epilepsy Study
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.

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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
  • Epilepsy
  • Epilepsies, Partial
Drug: oxcarbazepine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
June 2004
June 2004   (final data collection date for primary outcome measure)

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
Both
1 Month to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Germany,   Mexico
 
NCT00050934
CTRI476E 2340
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP