Study of the Interest of the Combination of Stiripentol (Diacomit®) and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biocodex
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Previous antiepileptic treatments received
研究概览
简要总结
This is a monocentric, open-label clinical study, presenting a retrospective part and a prospective part, studying the data of patients with drug-resistant focal epilepsies and treated with the combination of stiripentol (Diacomit®) and Carbamazepine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective part of the research:
- •The medical records of CRéER patients with the following criteria will be included in the retrospective part of the research by an investigator:
- •With pharmacoresistant epilepsy, i.e. a history of failure of two well-conducted and well-tolerated antiepileptic treatment regimens, either as monotherapy or as combination therapy,
- •Receiving or having received a treatment combining stiripentol and carbamazepine for a period of at least 15 days,
- •Having at least one evaluation data after the initiation of treatment with stiripentol and carbamazepine (a follow-up visit after the initiation of the study treatment),
- •For which an information note indicating the possibility of opposing the processing of data has been provided.
- •Prospective part of the research:
- •Among the patients whose medical records are included in the retrospective part of the research, those who meet the following criteria will be able to participate in the prospective part of the research:
- •Currently treated with stiripentol in combination with carbamazepine for at least 15 days and still being followed in the center,
- •Weighing at least 5 kg (minimum weight in accordance with the blood volume taken),
- •Having read, or whose parents have read, the information note and signed the consent form. For children, if their level of understanding allows it, their consent will also be sought,
- •Having sufficient knowledge, or whose parents or legal guardians have sufficient knowledge, of the French language to read, understand and complete the research documents,
- •Members or beneficiaries of a social security scheme. These patients, both children and adults, will be welcomed at the CIC.
排除标准
- •Retrospective part of the research : Patients objecting to the collection of their data will not participate in the research.
- •Prospective part of the research :
- •Patients with the following criteria will not be able to participate in the prospective part of the research:
- •Participating simultaneously in another interventional clinical trial or in a period of exclusion following a previous trial,
- •Whose state of health does not allow him to give his consent,
- •Under guardianship or curatorship,
- •Under judicial protection or person deprived of liberty.
研究组 & 干预措施
stiripentol
干预措施: Stiripentol (Drug)
结局指标
主要结局
Previous antiepileptic treatments received
时间窗: through study completion, an average of 1 year
proportion of patients having received each antiepileptic treatment; for the treatments received, description of the reasons for stopping.
Surgery
时间窗: through study completion, an average of 1 year
proportion of patients having undergone epilepsy surgery.
monthly seizures over the time
时间窗: through study completion, an average of 1 year
description of the average number of monthly seizures since the last visit (total and by type of seizure)
status epilepticus in the past
时间窗: through study completion, an average of 1 year
proportion of patients who presented with status epilepticus
emergency room consultation and/or hospitalization over the time
时间窗: through study completion, an average of 1 year
Proportion of patients requiring an emergency room consultation and/or hospitalized during the period preceding the visit.
emergency antiepileptic treatment over the time
时间窗: through study completion, an average of 1 year
Proportion of patients taking emergency antiepileptic treatment in the period before each visit
Age
时间窗: through study completion, an average of 1 year
Age of onset, nature of the first seizure and description of the type of the first seizure.
Adjustment of carbamazepine treatment over the time
时间窗: through study completion, an average of 1 year
mean and median duration of treatment, mean and median daily dose received, dose change(s) during treatment...
Adjustment of stiripentol treatment over the time
时间窗: through study completion, an average of 1 year
mean and median duration of treatment, mean and median daily dose received, dose change(s) during treatment...
Adjustment of concomitant treatments over the time
时间窗: through study completion, an average of 1 year
continuation without change, change in dosage, discontinuation
frequency of the status epileticus over the time
时间窗: through study completion, an average of 1 year
frequency of status epilepticus
duration of the status epileticus over the time
时间窗: through study completion, an average of 1 year
duration of status epilepticus
次要结局
- Response to the combination(through study completion, an average of 1 year)
- Tolerance of the combination.(through study completion, an average of 1 year)
- Retention rate of the combination(through study completion, an average of 1 year)
- Frequency and nature of the adverse events over the time(through study completion, an average of 1 year)
- Abnormal biological parameters (NFS and liver)(through study completion, an average of 1 year)