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Completed

NCT Number: NCT05419180

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

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.

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Key information

Conditions

Pharmacoresistant Focal Epilepsies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

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:

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

Treatment and study plan

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.

Primary outcomes

  1. Age

    Time frame: through study completion, an average of 1 year

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

  2. Previous antiepileptic treatments received

    Time frame: through study completion, an average of 1 year

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

  3. Surgery

    Time frame: through study completion, an average of 1 year

    proportion of patients having undergone epilepsy surgery.

  4. Adjustment of carbamazepine treatment over the time

    Time frame: through study completion, an average of 1 year

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

  5. Adjustment of stiripentol treatment over the time

    Time frame: through study completion, an average of 1 year

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

  6. Adjustment of concomitant treatments over the time

    Time frame: through study completion, an average of 1 year

    continuation without change, change in dosage, discontinuation

  7. monthly seizures over the time

    Time frame: through study completion, an average of 1 year

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

  8. status epilepticus in the past

    Time frame: through study completion, an average of 1 year

    proportion of patients who presented with status epilepticus

  9. duration of the status epileticus over the time

    Time frame: through study completion, an average of 1 year

    duration of status epilepticus

  10. emergency room consultation and/or hospitalization over the time

    Time frame: through study completion, an average of 1 year

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

  11. emergency antiepileptic treatment over the time

    Time frame: through study completion, an average of 1 year

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

  12. frequency of the status epileticus over the time

    Time frame: through study completion, an average of 1 year

    frequency of status epilepticus

Secondary outcomes

  1. Retention rate of the combination

    Time frame: through study completion, an average of 1 year

    The retention rate of the combination will correspond to the proportion of patients still receiving the combination (carbamazepine and stiripentol) at a given time.

  2. Response to the combination

    Time frame: through study completion, an average of 1 year

    The rate of patients responding to the combination will be defined by the percentage of patients in whom a 50% reduction in visible seizures will be observed since the initiation of the carbamazepine and stiripentol combination.

    Will be estimated:

    oThe percentage of responder patients at the post-initiation visit of the combination (first follow-up visit after initiation of stiripentol) oThe percentage of responder patients during treatment regardless of the duration of treatment after which the response is obtained.

    oThe cumulative incidence of responder patients.

  3. Tolerance of the combination.

    Time frame: through study completion, an average of 1 year

    Proportion of patients with Adverse Effects (AEs) related to the combination or to one of the treatments,

  4. Frequency and nature of the adverse events over the time

    Time frame: through study completion, an average of 1 year

    Frequency and nature of the adverse events over the time

  5. Abnormal biological parameters (NFS and liver)

    Time frame: through study completion, an average of 1 year

    proportion of patients with abnormal laboratory values (NFS and liver function) during

Other outcomes

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

    Time frame: through study completion, an average of 1 year

    Cmax calculation

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

    Time frame: through study completion, an average of 1 year

    AUC0-8 calculation

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

    Time frame: through study completion, an average of 1 year

    AUC0-24 calculation

  4. Time of Maximum (Tmax)concentration for stiripentol, carbamazepines and its metabolites

    Time frame: through study completion, an average of 1 year

    Tmax calculation

  5. half-life (t1/2) for stiripentol, carbamazepines and its metabolites

    Time frame: through study completion, an average of 1 year

    t1/2 calculation

  6. Pre-dose trough concentration (Ctrough) for stiripentol, carbamazepines and its metabolites

    Time frame: through study completion, an average of 1 year

    Ctrough calculation

Sponsors and collaborators

Lead sponsor

Biocodex

Industry

Registry information

Official study title

Study of the Interest of the Combination of Stiripentol (Diacomit®) and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2022
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.