Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

Novartis80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy, Partial Seizures

Interventions

OxcarbazepineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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.

Locations (7)

Epilepsy Department of the Moscow Research Institute of Psychiatry

Moscow, Russia

Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University

Moscow, Russia

Neurology and Neurosurgery Department of the Russian State Medical University

Moscow, Russia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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