LevetIracetam in Patients Being Treated for Epilepsy (LIBERTY)
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
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
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Thessaloniki, 그리스
- Papageorgiou Hospital
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Attica
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Athens, Attica, 그리스
- Gennimatas General State Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in seizures' status (Change of number of seizures from baseline)
기간: 12 months
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Change of number of seizures from baseline
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12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in adverse events
기간: 12 months
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Change of number of adverse events from baseline
|
12 months
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Change in treatment cost
기간: 12 months
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Change in treatment cost from baseline
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12 months
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Change in Quality of Life
기간: 12 months
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Change in QoLie score from baseline
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12 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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. Erratum In: J Neurol Neurosurg Psychiatry 1997 Jun;62(6):679.
- 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. Erratum In: Qual Life Res. 2007 Mar;16(2):361. Haritomeni, Piperidou [corrected to Piperidou, Haritomeni]; Aikaterini, Terzoudi [corrected to Terzoudi, Aikaterini]; Theofanis, Vorvolakos [corrected to Vorvolakos, Theofanis]; Elizabeth, Davis [corrected to Davis, Elizabeth]; Ioannis, Heliopoulos [correc.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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