Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution
18 ноября 2014 г. обновлено: UCB Pharma
Observational Sentinel Sites Study in Infants Younger Than 12 Months Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution in Usual Clinical Practice
The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice.
Their data will be collected until they reach the age of 13 months.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
This non-interventional sentinel sites post-authorization safety study (PASS) aims to collect additional data on use of Keppra® (Levetiracetam) oral solution in clinical practice, and on efficacy and safety of Keppra® (Levetiracetam) in infants younger than12 months.
Epileptic patients between the age of 1 month and 11 months inclusive can be invited for participation to the non-interventional sentinel sites PASS, after the physician has decided to initiate therapy with Keppra® (Levetiracetam) oral solution (100 mg/ml bottle) and patient has so far been treated with Keppra® (Levetiracetam) for no longer than 10 days.
The patients will be followed and their data will be collected until they reach the age of 13 months.
Тип исследования
Наблюдательный
Регистрация (Действительный)
101
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Berlin, Германия
- 027
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Bielefeld, Германия
- 024
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Heidelberg, Германия
- 026
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Kehl Kork, Германия
- 021
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Kiel, Германия
- 023
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Muenster, Германия
- 022
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Athens, Греция
- 072
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Patras, Греция
- 071
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Barcelona, Испания
- 043
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Madrid, Испания
- 044
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Madrid, Испания
- 045
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Murcia, Испания
- 046
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Bologna, Италия
- 037
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Calambrone, Италия
- 031
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Milano, Италия
- 032
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Roma, Италия
- 034
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Verona, Италия
- 035
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Gdansk, Польша
- 065
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Lodz, Польша
- 064
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Szczecin, Польша
- 063
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Warszawa, Польша
- 062
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Birmingham, Соединенное Королевство
- 057
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Liverpool, Соединенное Королевство
- 052
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London, Соединенное Королевство
- 051
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Amiens, Франция
- 012
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Bron, Франция
- 010
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Paris, Франция
- 011
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 1 месяц до 11 месяцев (Ребенок)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Метод выборки
Невероятностная выборка
Исследуемая популяция
Patients coming to day clinic for consultation by specialist
Описание
Inclusion Criteria:
- diagnosis of epilepsy
- being treated with Keppra® Oral Solution
- aged between 1 month and 11 months inclusive at study baseline
Exclusion Criteria:
- none
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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Patients, 1 - 11 months old, prescribed Keppra® oral solution
Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who are between 1 and 11 months old.
The patients will be followed as per current clinical practices for their condition.
The choice of medical treatment, including the concomitant use of other antiepileptic drugs, is made independently by the physician in the regular course of practice and is not influenced by the study protocol.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
Временное ограничение: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).
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From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up
Временное ограничение: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
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Number of patients with any serious Treatment-Emergent Adverse Events (TEAEs) during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).
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From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
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Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit
Временное ограничение: From Baseline through the last Treatment Visit (maximum 12 months)
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Number of patients with any Treatment-Emergent Adverse Events (TEAEs) leading to temporary or permanent discontinuation of Keppra® (Levetiracetam) during the Treatment Period (maximum 12 months).
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From Baseline through the last Treatment Visit (maximum 12 months)
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Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit
Временное ограничение: From Baseline to the last Treatment Visit (maximum 12 months)
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Number of patients with presence of deviation from the normal milestones of psychomotor development during the Treatment Period (maximum 12 months).
The treating physician evaluated at each visit, as part of standard clinical practice, the psychomotor development of the patient.
The evaluation of the patient's psychomotor development was categorized by the motor development, the social development and the language development.
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From Baseline to the last Treatment Visit (maximum 12 months)
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Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit
Временное ограничение: From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
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For each visit, body weight was measured and standardization for gender and age was performed based on WHO growth charts to obtain z-scores.
For this outcome measure, the mean of the differences of individual body weight z-scores from Safety Follow-up Visit to Baseline was determined.
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From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
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Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit
Временное ограничение: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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For each visit, body length was measured and age standardization was performed based on WHO growth charts to obtain z-scores.
For this outcome measure, the difference of body length z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.
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From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit
Временное ограничение: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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For each visit, head circumference was measured and age standardization was performed based on WHO growth charts to obtain z-scores.
For this outcome measure, the difference of head circumference z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.
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From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit
Временное ограничение: From Baseline to the last Treatment Visit (maximum 12 months)
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Number of patients with abnormalities noted during physical examination over the Treatment Period (maximum 12 months). Any abnormal findings during the physical examination during the study were reported as Adverse Events (AEs). The Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit cannot be given because abnormalities at Screening are listed only and worsening after Screening were handled as AEs and tabulated along with the other AEs. |
From Baseline to the last Treatment Visit (maximum 12 months)
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Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit
Временное ограничение: From Baseline to the last Treatment Visit (maximum 12 months)
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The Number of Patients With Abnormalities Noted During Neurological Examination cannot be given because abnormality frequencies were only determined for single parameters of the neurological examination and therefore a subject might have been counted several times.
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From Baseline to the last Treatment Visit (maximum 12 months)
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Global Evaluation Scale of the Psychomotor Development (GES)
Временное ограничение: From Baseline to the last Treatment Visit (maximum 12 months)
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Global evaluation scale of the psychomotor development (GES): physician's assessment of the change from Baseline in the psychomotor development at the last Treatment Visit (maximum timeframe is 12 months). The GES is a 7-point scale with the following options: 7=Marked improvement 6=Moderate improvement 5=Slight improvement 4=No Change 3=Slight worsening 2=Moderate worsening 1=Marked worsening As a variant of this variable, a 3-class variable was derived as follows
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From Baseline to the last Treatment Visit (maximum 12 months)
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Global Evaluation Scale of Epilepsy Severity (GES)
Временное ограничение: From Baseline to the last Treatment Visit (maximum time frame is 12 months)
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Global evaluation scale of epilepsy severity (GES): physician's assessment of the change from Baseline of the epilepsy severity at the last Treatment Visit (maximum 12 months). The GES is a 7-point scale that assesses change in the severity of the patient's illness. The GES is a 7-point scale with the following options: 7=Marked improvement 6=Moderate improvement 5=Slight improvement 4=No Change 3=Slight worsening 2=Moderate worsening 1=Marked worsening As a variant of this variable, a 3-class variable was derived as follows
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From Baseline to the last Treatment Visit (maximum time frame is 12 months)
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Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period
Временное ограничение: From Baseline through the last Treatment Visit (maximum 12 months)
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Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).
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From Baseline through the last Treatment Visit (maximum 12 months)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 января 2011 г.
Первичное завершение (Действительный)
1 ноября 2013 г.
Завершение исследования (Действительный)
1 ноября 2013 г.
Даты регистрации исследования
Первый отправленный
23 сентября 2010 г.
Впервые представлено, что соответствует критериям контроля качества
27 сентября 2010 г.
Первый опубликованный (Оценивать)
28 сентября 2010 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
19 ноября 2014 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
18 ноября 2014 г.
Последняя проверка
1 ноября 2014 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- N01357
- 2009-017333-21 (Номер EudraCT)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .