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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 31, 2014