Pediatric Epilepsy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00050934
Recruitment Status : Completed
First Posted : January 1, 2003
Last Update Posted : November 23, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Epilepsy Epilepsies, Partial Drug: oxcarbazepine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
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.
Study Start Date : June 2002
Primary Completion Date : June 2004
Study Completion Date : June 2004

Primary Outcome Measures :
  1. change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)

Secondary Outcome Measures :
  1. % 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00050934

  Show 30 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00050934     History of Changes
Other Study ID Numbers: CTRI476E 2340
First Posted: January 1, 2003    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
partial seizures

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents