Clinical trial NCT02356731: LevetIracetam in Patients Being Treated for Epilepsy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: seizures,
quality of life
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 450
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in seizures' status (Change of number of seizures from baseline)
timeFrame: 12 months
Secondary outcomes:
measure: Change in adverse events
timeFrame: 12 months
measure: Change in treatment cost
timeFrame: 12 months
measure: Change in Quality of Life
timeFrame: 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Gennimatas General State Hospital
state: Attica
city: Thessaloniki
country: Greece
facility: Papageorgiou Hospital
Study officials:
References:
citation: 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.
citation: 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.
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. doi: 10.1007/s11136-005-5149-9.
citation: 3. Hauser WA. Incidence and prevalence. In: ENGEL J Jr., PEDLEY A eds. Epilepsy: a comprehensive textbook. Philadelphia: Lippincot-Raven Publishers, 1997; 47-57
citation: ILAE Commission Report. The epidemiology of the epilepsies: future directions. International League Against Epilepsy. Epilepsia. 1997 May;38(5):614-8. No abstract available.
citation: 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.
citation: 8. ENGEL J Jr. The epilepsies. In: Wyngaarden JB, Smith LH, Claude Bennet J (eds) Cecil Textbook of Medicine. Saunders, Philadelphia, 1992:2202-2213
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. doi: 10.1111/j.1600-0404.1992.tb05124.x.
citation: 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.