LevetIracetam in Patients Being Treated for Epilepsy (LIBERTY)

January 16, 2017 updated by: Elpen Pharmaceutical Co. Inc.

The Diagnosis and Management of Patients With Epilepsy: Nationwide, Multicenter Study of Recordings for the Diagnosis and Management of Patients With Epilepsy and Treatment With Levetiracetam in Daily Clinical Practice in Greece

Epilepsy is one of the most common neurological diseases.Approximately 53 million people suffering from chronic recurrent epilepsy in 1990 and that number increased about 58 million in 2005.

The annual incidence of epilepsy varies considerably in different epidemiological studies, ranging from 11 cases per 100,000 general population to 230 cases per 100,000 people.

To date there has been discovered the ideal Antiepileptic Drugs. The drug, ie, that are safe and effective, it has good daily administration frequency, easily administered from all roads, which has high bioavailability, which is not highly bound to proteins, and not holding inductive or inhibitory effect.

Study Overview

Status

Completed

Conditions

Detailed Description

There are broad-spectrum anticonvulsant, which means that a drug can be very effective for a patient, but may or may not regulate and increase the frequency of another crisis. Thus there remains now only to choose one among a number of drugs, the most appropriate.This study intends to register within 12 months clinical practice in Greek reality as regards the elements of diagnosis and management of patients with epilepsy and those who already are, or are part of treatment with levetiracetam.

The aims of this clinical study is to record data on

  • the diagnosis
  • The management of epilepsy in daily clinical practice in a sample of Greek population
  • The monitoring of patients entering or already undergoing treatment with levetiracetam.
  • The assessment of quality of life between visits of the study by using quality of life QOLIE-31 questionnaire
  • The economic evaluation of the change in treatment from original to generic levetiracetam This is a data recording study and evaluation of treatment with levetiracetam. The study will take place in 15 antiepileptic centers throughout Greece. Researchers will have to successively record all incidents of patients (30 per center) with epilepsy, which are new diagnoses or already diagnosed and are treated with levetiracetam.

Study Type

Observational

Enrollment (Actual)

450

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

  • Greece
      • Thessaloniki, Greece
        • Papageorgiou Hospital
    • Attica
      • Athens, Attica, Greece
        • Gennimatas General State Hospital

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

6 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will recruit outpatients who are new epilepsy diagnoses or diagnosed prior to enrollment in the study and treated with levetiracetam for the management of their disease. All patients will be included from 15 research centers nationwide. Each center will include ≥30 patients to be monitored (1: 1 newly diagnosed / older diagnoses).

Description

Inclusion Criteria:

  • Outpatients
  • Males and Females
  • Age> 6 years
  • Patients diagnosed with epilepsy or
  • Patients who are diagnosed and treated with antiepileptic treatment levetiracetam
  • Patients who consent to their participation in the study
  • Patients will comply with the requirements and procedures of the study

Exclusion Criteria:

  • Patients who did not consent to their participation in the study
  • Patients who will not comply to the needs and the design process

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in seizures' status (Change of number of seizures from baseline)
Time Frame: 12 months
Change of number of seizures from baseline
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in adverse events
Time Frame: 12 months
Change of number of adverse events from baseline
12 months
Change in treatment cost
Time Frame: 12 months
Change in treatment cost from baseline
12 months
Change in Quality of Life
Time Frame: 12 months
Change in QoLie score from baseline
12 months

Collaborators and Investigators

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

Sponsor

Elpen Pharmaceutical Co. Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-LVT-EL-54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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