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Completed

NCT Number: NCT00275912

Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

This study is aimed to collect additional data regarding the efficacy in reducing the frequency of partial seizures, as well as the safety and tolerability, of oxcarbazepine monotherapy in children.

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Key information

Conditions

Epilepsy, Partial Seizures Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery, Moscow, Russia

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males and females, 6 months - 17 years of age;
  • diagnosis of epilepsy, partial seizures;
  • ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous antiepileptic therapy

Exclusion criteria

  • progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;
  • non-epileptic seizures;
  • drug or alcohol dependence during a year prior to screening;

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Oxcarbazepine

Drug

Primary outcomes

  1. Epileptic activity at electroencephalography in rest

  2. Flash light and hyperventilation test with electroencephalography

  3. Frequency of epileptic episodes according to patient's diary

  4. Electrocardiogram analysis for rhythm and conduction

  5. Blood test for sodium, hepatic enzymes and blood cells

Secondary outcomes

  1. Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in children with partial seizures

  2. Rate of patients with total and partial control of epilepsy

  3. Rate of patients requiring additional antiepileptic drugs

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 24-week Prospective Open-label Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 12, 2006
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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