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

NCT05419180 | Completed Phase 4

• 1 other identifier: CARBASTIR (STP225)
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (12)

• Age

  Age of onset, nature of the first seizure and description of the type of the first seizure.

  through study completion, an average of 1 year

• Previous antiepileptic treatments received

  proportion of patients having received each antiepileptic treatment; for the treatments received, description of the reasons for stopping.

  through study completion, an average of 1 year

• Surgery

  proportion of patients having undergone epilepsy surgery.

  through study completion, an average of 1 year

• Adjustment of carbamazepine treatment over the time

  mean and median duration of treatment, mean and median daily dose received, dose change(s) during treatment...

  through study completion, an average of 1 year

• Adjustment of stiripentol treatment over the time

  mean and median duration of treatment, mean and median daily dose received, dose change(s) during treatment...

  through study completion, an average of 1 year

• Adjustment of concomitant treatments over the time

  continuation without change, change in dosage, discontinuation

  through study completion, an average of 1 year

• monthly seizures over the time

  description of the average number of monthly seizures since the last visit (total and by type of seizure)

  through study completion, an average of 1 year

• status epilepticus in the past

  proportion of patients who presented with status epilepticus

  through study completion, an average of 1 year

• duration of the status epileticus over the time

  duration of status epilepticus

  through study completion, an average of 1 year

• emergency room consultation and/or hospitalization over the time

  Proportion of patients requiring an emergency room consultation and/or hospitalized during the period preceding the visit.

  through study completion, an average of 1 year

• emergency antiepileptic treatment over the time

  Proportion of patients taking emergency antiepileptic treatment in the period before each visit

  through study completion, an average of 1 year

• frequency of the status epileticus over the time

  frequency of status epilepticus

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Retention rate of the combination

  through study completion, an average of 1 year

• Response to the combination

  through study completion, an average of 1 year

• Tolerance 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

Other Outcomes (6)

• Maximum Concentration (Cmax) for stiripentol, carbamazepines and its metabolites

  through study completion, an average of 1 year

• Area under the plasma concentration versus time curve (AUC) 0-8 for stiripentol, carbamazepines and its metabolites

  through study completion, an average of 1 year

• Area under the plasma concentration versus time curve (AUC) 0-24 for stiripentol, carbamazepines and its metabolites

  through study completion, an average of 1 year

Study Arms (1)

stiripentol

OTHER

Drug: Stiripentol

Interventions

Stiripentol 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.

stiripentol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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:
• Whose state of health does not allow him to give his consent,
• Under guardianship or curatorship,
• Under judicial protection or person deprived of liberty.

Sponsors & Collaborators

• Biocodex: lead

Study Sites (1)

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

Paris, 75015, France

Location

MeSH Terms

Interventions

stiripentol

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: retrospective part and prospective part

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 15, 2022
• Study Start: October 13, 2022
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: July 24, 2024

Record last verified: 2022-05

Locations

FR (1)