Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
450 participants
OBSERVATIONAL
2015-03-31
2016-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 will not comply to the needs and the design process
6 Years
80 Years
ALL
No
Sponsors
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Elpen Pharmaceutical Co. Inc.
INDUSTRY
Responsible Party
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Locations
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Gennimatas General State Hospital
Athens, Attica, Greece
Papageorgiou Hospital
Thessaloniki, Thessaloniki, Greece
Countries
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References
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Hauser WA. Recent developments in the epidemiology of epilepsy. Acta Neurol Scand Suppl. 1995;162:17-21. doi: 10.1111/j.1600-0404.1995.tb00493.x.
Sander JW, Shorvon SD. Epidemiology of the epilepsies. J Neurol Neurosurg Psychiatry. 1996 Nov;61(5):433-43. doi: 10.1136/jnnp.61.5.433. No abstract available.
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. doi: 10.1007/s11136-005-5149-9.
3. Hauser WA. Incidence and prevalence. In: ENGEL J Jr., PEDLEY A eds. Epilepsy: a comprehensive textbook. Philadelphia: Lippincot-Raven Publishers, 1997; 47-57
ILAE Commission Report. The epidemiology of the epilepsies: future directions. International League Against Epilepsy. Epilepsia. 1997 May;38(5):614-8. No abstract available.
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. doi: 10.1016/0140-6736(90)92960-p.
8. ENGEL J Jr. The epilepsies. In: Wyngaarden JB, Smith LH, Claude Bennet J (eds) Cecil Textbook of Medicine. Saunders, Philadelphia, 1992:2202-2213
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. doi: 10.1111/j.1600-0404.1992.tb05124.x.
Trimble MR. Anticonvulsant drugs and cognitive function: a review of the literature. Epilepsia. 1987;28 Suppl 3:S37-45. doi: 10.1111/j.1528-1157.1987.tb05776.x.
Other Identifiers
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2015-LVT-EL-54
Identifier Type: -
Identifier Source: org_study_id
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