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Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

NCT ID: NCT00275925

Last Updated: 2007-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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Conditions

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Epilepsy, Partial Seizures

Keywords

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partial epilepsy, oxcarbazepine, adults

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oxcarbazepine

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Epilepsy Department of the Moscow Research Institute of Psychiatry

Moscow, , Russia

Site Status

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

Moscow, , Russia

Site Status

Neurology and Neurosurgery Department of the Russian State Medical University

Moscow, , Russia

Site Status

Neurology Department of I.M. Sechenov Moscow Medical Academy

Moscow, , Russia

Site Status

Neurology Department of Pediatric faculty of the Russian State Medical University

Moscow, , Russia

Site Status

Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy

Moscow, , Russia

Site Status

Epilepsy Department of the V.M. Bekhterev Sant-Petersburg Psychoneurology Institute

Saint Petersburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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CTRI476BRU01

Identifier Type: -

Identifier Source: org_study_id