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LevetIracetam in Patients Being Treated for Epilepsy (LIBERTY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02356731
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Epilepsy

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.

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Study Type : Observational
Actual Enrollment : 450 participants
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures




Primary Outcome Measures :
  1. Change in seizures' status (Change of number of seizures from baseline) [ Time Frame: 12 months ]
    Change of number of seizures from baseline


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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

Information from the National Library of Medicine

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


Locations
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Greece
Gennimatas General State Hospital
Athens, Attica, Greece
Papageorgiou Hospital
Thessaloniki, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.

Publications of Results:
3. Hauser WA. Incidence and prevalence. In: ENGEL J Jr., PEDLEY A eds. Epilepsy: a comprehensive textbook. Philadelphia: Lippincot-Raven Publishers, 1997; 47-57
8. ENGEL J Jr. The epilepsies. In: Wyngaarden JB, Smith LH, Claude Bennet J (eds) Cecil Textbook of Medicine. Saunders, Philadelphia, 1992:2202-2213

Other Publications:
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Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT02356731     History of Changes
Other Study ID Numbers: 2015-LVT-EL-54
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Elpen Pharmaceutical Co. Inc.:
seizures,
quality of life

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents