Study of Interest of Stiripentol and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies

Last updated: July 23, 2024
Sponsor: Biocodex
Overall Status: Completed

Phase

4

Condition

Epilepsy

Treatment

Stiripentol

Clinical Study ID

NCT05419180
CARBASTIR (STP225)
  • All Genders

Study Summary

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.

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:

  1. With pharmacoresistant epilepsy, i.e. a history of failure of two well-conducted andwell-tolerated antiepileptic treatment regimens, either as monotherapy or ascombination therapy,

  2. Receiving or having received a treatment combining stiripentol and carbamazepine fora period of at least 15 days,

  3. Having at least one evaluation data after the initiation of treatment withstiripentol and carbamazepine (a follow-up visit after the initiation of the studytreatment),

  4. 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:

  1. Currently treated with stiripentol in combination with carbamazepine for at least 15days and still being followed in the center,

  2. Weighing at least 5 kg (minimum weight in accordance with the blood volume taken),

  3. 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,

  4. Having sufficient knowledge, or whose parents or legal guardians have sufficientknowledge, of the French language to read, understand and complete the researchdocuments,

  5. 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:

  1. Participating simultaneously in another interventional clinical trial or in a periodof exclusion following a previous trial,

  2. Whose state of health does not allow him to give his consent,

  3. Under guardianship or curatorship,

  4. Under judicial protection or person deprived of liberty.

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Stiripentol
Phase: 4
Study Start date:
October 13, 2022
Estimated Completion Date:
June 13, 2024

Connect with a study center

  • Centre de Référence Epilepsies Rares / Centre Investigation Clinique (CIC) - Hôpital Necker-Enfants Malades

    Paris, 75015
    France

    Site Not Available

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