LevetIracetam in Patients Being Treated for Epilepsy

Completed

• Conditions: Epilepsy

• Registration Number: NCT02356731
• Lead Sponsor: Elpen Pharmaceutical Co. Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-01-23
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-05
• Study Start: 2015-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in seizures' status (Change of number of seizures from baseline)	12 months	Change of number of seizures from baseline

Secondary Outcome Measures

Name	Time	Method
Change in adverse events	12 months	Change of number of adverse events from baseline
Change in treatment cost	12 months	Change in treatment cost from baseline
Change in Quality of Life	12 months	Change in QoLie score from baseline

Trial Locations

Locations (2)

Gennimatas General State Hospital; 🇬🇷 Athens, Attica, Greece

Papageorgiou Hospital; 🇬🇷 Thessaloniki, Greece