Clinical trial NCT05419180: Study of Interest of Stiripentol and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies
Official title: Study of the Interest of the Combination of Stiripentol (Diacomit®) and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharmacoresistant Focal Epilepsies
Lead sponsor: Biocodex
Sponsor class: INDUSTRY
First posted: 2022-06-15
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: retrospective part and prospective part
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Age
timeFrame: through study completion, an average of 1 year
measure: Previous antiepileptic treatments received
timeFrame: through study completion, an average of 1 year
measure: Surgery
timeFrame: through study completion, an average of 1 year
measure: Adjustment of carbamazepine treatment over the time
timeFrame: through study completion, an average of 1 year
measure: Adjustment of stiripentol treatment over the time
timeFrame: through study completion, an average of 1 year
measure: Adjustment of concomitant treatments over the time
timeFrame: through study completion, an average of 1 year
measure: monthly seizures over the time
timeFrame: through study completion, an average of 1 year
measure: status epilepticus in the past
timeFrame: through study completion, an average of 1 year
measure: duration of the status epileticus over the time
timeFrame: through study completion, an average of 1 year
measure: emergency room consultation and/or hospitalization over the time
timeFrame: through study completion, an average of 1 year
measure: emergency antiepileptic treatment over the time
timeFrame: through study completion, an average of 1 year
measure: frequency of the status epileticus over the time
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Retention rate of the combination
timeFrame: through study completion, an average of 1 year
measure: Response to the combination
timeFrame: through study completion, an average of 1 year
measure: Tolerance of the combination.
timeFrame: through study completion, an average of 1 year
measure: Frequency and nature of the adverse events over the time
timeFrame: through study completion, an average of 1 year
measure: Abnormal biological parameters (NFS and liver)
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Maximum Concentration (Cmax) for stiripentol, carbamazepines and its metabolites
timeFrame: through study completion, an average of 1 year
measure: Area under the plasma concentration versus time curve (AUC) 0-8 for stiripentol, carbamazepines and its metabolites
timeFrame: through study completion, an average of 1 year
measure: Area under the plasma concentration versus time curve (AUC) 0-24 for stiripentol, carbamazepines and its metabolites
timeFrame: through study completion, an average of 1 year
measure: Time of Maximum (Tmax)concentration for stiripentol, carbamazepines and its metabolites
timeFrame: through study completion, an average of 1 year
measure: half-life (t1/2) for stiripentol, carbamazepines and its metabolites
timeFrame: through study completion, an average of 1 year
measure: Pre-dose trough concentration (Ctrough) for stiripentol, carbamazepines and its metabolites
timeFrame: through study completion, an average of 1 year
Locations:
city: Paris
country: France
facility: Centre de Référence Epilepsies Rares / Centre Investigation Clinique (CIC) - Hôpital Necker-Enfants Malades
Study officials:
References: