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Completed

NCT Number: NCT02356731

LevetIracetam in Patients Being Treated for Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gennimatas General State Hospital, Athens, Attica, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in seizures' status (Change of number of seizures from baseline)

    Time frame: 12 months

    Change of number of seizures from baseline

Secondary outcomes

  1. Change in adverse events

    Time frame: 12 months

    Change of number of adverse events from baseline

  2. Change in treatment cost

    Time frame: 12 months

    Change in treatment cost from baseline

  3. Change in Quality of Life

    Time frame: 12 months

    Change in QoLie score from baseline

Sponsors and collaborators

Lead sponsor

Elpen Pharmaceutical Co. Inc.

Industry

Registry information

Official study 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

Acronym: LIBERTY

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2015
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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