Pharmacoresistant Focal EpilepsiesPhase 4NCT05419180
Study of Interest of Stiripentol and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies
A Phase 4 study testing Stiripentol in people with Pharmacoresistant Focal Epilepsies, run by Biocodex at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pharmacoresistant Focal Epilepsies
- What is being tested?
- Stiripentol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2022to 13 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Référence Epilepsies Rares / Centre Investigation Clinique (CIC) - Hôpital Necker-Enfants Malades
Paris, 75015
About this study
Official title: 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.
- Conditions
- Pharmacoresistant Focal Epilepsies
- Being tested
- Stiripentol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StiripentolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| stiripentol | Other | Not described Receives: Drug: Stiripentol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age of onset, nature of the first seizure and description of the type of the first seizure.
Measured: 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.
Measured: through study completion, an average of 1 year
Surgery
proportion of patients having undergone epilepsy surgery.
Measured: 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...
Measured: 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...
Measured: through study completion, an average of 1 year
Adjustment of concomitant treatments over the time
continuation without change, change in dosage, discontinuation
Measured: 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)
Measured: through study completion, an average of 1 year
status epilepticus in the past
proportion of patients who presented with status epilepticus
Measured: through study completion, an average of 1 year
duration of the status epileticus over the time
duration of status epilepticus
Measured: 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.
Measured: 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
Measured: through study completion, an average of 1 year
frequency of the status epileticus over the time
frequency of status epilepticus
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Retention rate of the combination
The retention rate of the combination will correspond to the proportion of patients still receiving the combination (carbamazepine and stiripentol) at a given time.
Measured: through study completion, an average of 1 year
Response to the combination
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.
Measured: through study completion, an average of 1 year
Tolerance of the combination.
Proportion of patients with Adverse Effects (AEs) related to the combination or to one of the treatments,
Measured: through study completion, an average of 1 year
Frequency and nature of the adverse events over the time
Frequency and nature of the adverse events over the time
Measured: through study completion, an average of 1 year
Abnormal biological parameters (NFS and liver)
proportion of patients with abnormal laboratory values (NFS and liver function) during
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start13 Oct 2022
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacoresistant Focal EpilepsiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- retrospective part and prospective part
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419180
- Sponsor's protocol ID
- CARBASTIR (STP225)
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Interest of the Combination of Stiripentol (Diacomit®) and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies
- ClinicalTrials.gov ID
- NCT05419180
- Acronym / sponsor ID
- CARBASTIR (STP225)
- Conditions
- Pharmacoresistant Focal Epilepsies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- retrospective part and prospective part
| Arm | Type | Receives |
|---|---|---|
| stiripentol | Other | Drug: Stiripentol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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),
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StiripentolSince the treatment usually received by patients should not be modified, the sponsor will not intervene in any way in the therapeutic management of patients. | Drug | stiripentol |
Primary outcome
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.
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.
Surgery
Time frame: through study completion, an average of 1 year
proportion of patients having undergone epilepsy surgery.
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...
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...
Adjustment of concomitant treatments over the time
Time frame: through study completion, an average of 1 year
continuation without change, change in dosage, discontinuation
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)
status epilepticus in the past
Time frame: through study completion, an average of 1 year
proportion of patients who presented with status epilepticus
duration of the status epileticus over the time
Time frame: through study completion, an average of 1 year
duration of status epilepticus
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.
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
frequency of the status epileticus over the time
Time frame: through study completion, an average of 1 year
frequency of status epilepticus
5 secondary outcomes
Retention rate of the combination
Time frame: through study completion, an average of 1 year
Response to the combination
Time frame: through study completion, an average of 1 year
Tolerance of the combination.
Time frame: 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
Abnormal biological parameters (NFS and liver)
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stiripentol in people with Pharmacoresistant Focal Epilepsies, run by Biocodex at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: through study completion, an average of 1 year). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.