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

October 13, 2022 updated by: Biocodex

Study of the Interest of the Combination of Stiripentol (Diacomit®) 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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75015
        • Recruiting
        • Centre de Référence Epilepsies Rares / Centre Investigation Clinique (CIC) - Hôpital Necker-Enfants Malades
        • Principal Investigator:
          • Rima NABBOUT, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Surgery
Time Frame: through study completion, an average of 1 year
proportion of patients having undergone epilepsy surgery.
through study completion, an average of 1 year
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...
through study completion, an average of 1 year
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...
through study completion, an average of 1 year
Adjustment of concomitant treatments over the time
Time Frame: through study completion, an average of 1 year
continuation without change, change in dosage, discontinuation
through study completion, an average of 1 year
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)
through study completion, an average of 1 year
status epilepticus in the past
Time Frame: through study completion, an average of 1 year
proportion of patients who presented with status epilepticus
through study completion, an average of 1 year
duration of the status epileticus over the time
Time Frame: through study completion, an average of 1 year
duration of status epilepticus
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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
through study completion, an average of 1 year
frequency of the status epileticus over the time
Time Frame: through study completion, an average of 1 year
frequency of status epilepticus
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.

through study completion, an average of 1 year
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,
through study completion, an average of 1 year
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Concentration (Cmax) for stiripentol, carbamazepines and its metabolites
Time Frame: through study completion, an average of 1 year
Cmax calculation
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
Time Frame: through study completion, an average of 1 year
AUC0-8 calculation
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
Time Frame: through study completion, an average of 1 year
AUC0-24 calculation
through study completion, an average of 1 year
Time of Maximum (Tmax)concentration for stiripentol, carbamazepines and its metabolites
Time Frame: through study completion, an average of 1 year
Tmax calculation
through study completion, an average of 1 year
half-life (t1/2) for stiripentol, carbamazepines and its metabolites
Time Frame: through study completion, an average of 1 year
t1/2 calculation
through study completion, an average of 1 year
Pre-dose trough concentration (Ctrough) for stiripentol, carbamazepines and its metabolites
Time Frame: through study completion, an average of 1 year
Ctrough calculation
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 13, 2022

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (ACTUAL)

June 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CARBASTIR (STP225)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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