Phase
Condition
Epilepsy
Treatment
Stiripentol
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 andwell-tolerated antiepileptic treatment regimens, either as monotherapy or ascombination therapy,
Receiving or having received a treatment combining stiripentol and carbamazepine fora period of at least 15 days,
Having at least one evaluation data after the initiation of treatment withstiripentol and carbamazepine (a follow-up visit after the initiation of the studytreatment),
For which an information note indicating the possibility of opposing the processingof 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 15days 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 consentform. For children, if their level of understanding allows it, their consent willalso be sought,
Having sufficient knowledge, or whose parents or legal guardians have sufficientknowledge, of the French language to read, understand and complete the researchdocuments,
Members or beneficiaries of a social security scheme. These patients, both childrenand adults, will be welcomed at the CIC.
Exclusion
Exclusion Criteria:
Retrospective part of the research : Patients objecting to the collection of theirdata 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 periodof 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.
Study Design
Connect with a study center
Centre de Référence Epilepsies Rares / Centre Investigation Clinique (CIC) - Hôpital Necker-Enfants Malades
Paris, 75015
FranceSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.