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

NCT ID: NCT00275912

Last Updated: 2017-02-23

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-11

Study Completion Date

2007-09-28

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy, Partial Seizures

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, 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;
Minimum Eligible Age

6 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery

Moscow, , Russia

Site Status

Russian State Medical University clinically based on Russian Pediatric Clinical Hospital

Moscow, , Russia

Site Status

Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system

Moscow, , Russia

Site Status

St. Petersburg State Pediatrics Medical Academy

Saint Petersburg, , Russia

Site Status

Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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CTRI476BRU02

Identifier Type: -

Identifier Source: org_study_id

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