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Pediatric Epilepsy Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00050947
First Posted: January 1, 2003
Last Update Posted: November 23, 2011
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.

Condition Intervention Phase
Epilepsy Drug: oxcarbazepine Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Monotherapy in Pediatric Patients With Inadequately-controlled Partial Seizures.

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.

Secondary Outcome Measures:
  • Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase

Enrollment: 94
Study Start Date: July 2002
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA: To enter this study, patients must:

  • Have a diagnosis of partial seizures
  • Have 2-30 seizures per week while on a stable dose of one anti-epileptic drug or be a patient recently diagnosed with partial seizures and currently receiving no seizure medication
  • Be willing to be hospitalized for up to 5 days
  • Weigh a minimum of 6.6 lbs
  • 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
  • This study has some AED restrictions
  • 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
  • A history of substance abuse (including alcohol)
  • Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds
  • Used experimental medication within 30 days of entering this study
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00050947


  Show 30 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00050947     History of Changes
Other Study ID Numbers: CTRI476E2339
First Submitted: December 30, 2002
First Posted: January 1, 2003
Last Update Posted: November 23, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
partial seizures

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxcarbazepine
Carbamazepine
Anticonvulsants
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents