LevetIracetam in Patients Being Treated for Epilepsy

Epilepsy Clinical Trial

— LIBERTY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356731
• Other study ID #: 2015-LVT-EL-54
• Status: Completed
• Phase: N/A
• First received: January 23, 2015
• Last updated: January 16, 2017
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
Greece	Gennimatas General State Hospital	Athens	Attica
Greece	Papageorgiou Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Greece, 

References & Publications (9)

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

Hart YM, Sander JW, Johnson AL, Shorvon SD. National General Practice Study of Epilepsy: recurrence after a first seizure. Lancet. 1990 Nov 24;336(8726):1271-4. — View Citation

Hauser WA. Recent developments in the epidemiology of epilepsy. Acta Neurol Scand Suppl. 1995;162:17-21. Review. — View Citation

ILAE Commission Report. The epidemiology of the epilepsies: future directions. International League Against Epilepsy. Epilepsia. 1997 May;38(5):614-8. Review. — View Citation

Piperidou H, Terzoudi A, Vorvolakos T, Davis E, Heliopoulos I, Vadikolias K, Giassakis G, Aggelopoulos P, Georgios G, Karlovasitou A. The Greek version of the Quality of Life in Epilepsy Inventory (QOLIE-31). Qual Life Res. 2006 Jun;15(5):833-9. Erratum i — View Citation

Sander JW, Shorvon SD. Epidemiology of the epilepsies. J Neurol Neurosurg Psychiatry. 1996 Nov;61(5):433-43. Review. Erratum in: J Neurol Neurosurg Psychiatry 1997 Jun;62(6):679. — View Citation

Triantafyllou NI, Zalonis I, Kokotis P, Anthracopoulos M, Siafacas A, Malliara S, Hamburger HL, Papageorgiou C. Cognition in epilepsy: a multichannel event related potential (P300) study. Acta Neurol Scand. 1992 Nov;86(5):462-5. — View Citation

Trimble MR. Anticonvulsant drugs and cognitive function: a review of the literature. Epilepsia. 1987;28 Suppl 3:S37-45. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in seizures' status (Change of number of seizures from baseline)	Change of number of seizures from baseline	12 months
Secondary	Change in adverse events	Change of number of adverse events from baseline	12 months
Secondary	Change in treatment cost	Change in treatment cost from baseline	12 months
Secondary	Change in Quality of Life	Change in QoLie score from baseline	12 months