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

NCT ID: NCT05419180

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-13
• Study Completion Date: 2024-06-13

Brief 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.

Conditions

Pharmacoresistant Focal Epilepsies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stiripentol

Group Type: OTHER

Stiripentol

Intervention Type: DRUG

Since the treatment usually received by patients should not be modified, the sponsor will not intervene in any way in the therapeutic management of patients.

Interventions

Stiripentol

Since the treatment usually received by patients should not be modified, the sponsor will not intervene in any way in the therapeutic management of patients.

Intervention Type: DRUG

Eligibility Criteria

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 and well-tolerated antiepileptic treatment regimens, either as monotherapy or as combination therapy,

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

3. 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),

4. 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:

1. Currently treated with stiripentol in combination with carbamazepine for at least 15 days 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 consent form. For children, if their level of understanding allows it, their consent will also be sought,

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

5. Members or beneficiaries of a social security scheme. These patients, both children and adults, will be welcomed at the CIC.

Exclusion Criteria

• 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:

1. Participating simultaneously in another interventional clinical trial or in a period of 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocodex

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Paris, , France

Countries

France

Other Identifiers

CARBASTIR (STP225)

Identifier Type: -

Identifier Source: org_study_id