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
  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:


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 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 April 23, 2014