Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

November 29, 2007 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Epilepsy Department of the Moscow Research Institute of Psychiatry
      • Moscow, Russian Federation
        • Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University
      • Moscow, Russian Federation
        • Neurology and Neurosurgery Department of the Russian State Medical University
      • Moscow, Russian Federation
        • Neurology Department of I.M. Sechenov Moscow Medical Academy
      • Moscow, Russian Federation
        • Neurology Department of Pediatric faculty of the Russian State Medical University
      • Moscow, Russian Federation
        • Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy
      • Saint Petersburg, Russian Federation
        • Epilepsy Department of the V.M. Bekhterev Sant-Petersburg Psychoneurology Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria

January 11, 2006

First Posted (ESTIMATE)

January 12, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2007

Last Update Submitted That Met QC Criteria

November 29, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRI476BRU01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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