A 24-Week Prospective, Open-Label, Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Adult Patients With Partial Seizures

Novartis7 sites in 1 country80 target enrollmentDecember 2005

Overview

This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.

Registry

clinicaltrials.gov

Start Date

December 2005

End Date

March 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•males and females, 18 - 70 years of age;
•diagnosis of epilepsy, partial seizures;
•ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous therapy with antiepileptic drugs

•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.

Epileptic activity at electroencephalography in rest

Flash light and hyperventilation test with electroencephalography

Frequency of epileptic episodes according to patient's diary

Electrocardiogram analysis for rhythm and conduction

Blood test for sodium, hepatic enzymes and blood cells

Quality of Life assessment at baseline, last visit
Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in adult patients with partial seizures
Rate of patients with total and partial control of epilepsy
Rate of patients requiring additional antiepileptic drugs