LevetIracetam in Patients Being Treated for Epilepsy (LIBERTY)
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|ClinicalTrials.gov Identifier: NCT02356731|
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : January 18, 2017
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.
|Condition or disease|
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|
|Actual Enrollment :||450 participants|
|Official Title:||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|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
- Change in seizures' status (Change of number of seizures from baseline) [ Time Frame: 12 months ]Change of number of seizures from baseline
- Change in adverse events [ Time Frame: 12 months ]Change of number of adverse events from baseline
- Change in treatment cost [ Time Frame: 12 months ]Change in treatment cost from baseline
- Change in Quality of Life [ Time Frame: 12 months ]Change in QoLie score from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356731
|Gennimatas General State Hospital|
|Athens, Attica, Greece|