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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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.
Centre de Référence Epilepsies Rares / Centre Investigation Clinique (CIC) - Hôpital Necker-Enfants Malades
Paris, France
Age
Age of onset, nature of the first seizure and description of the type of the first seizure.
Time frame: 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.
Time frame: through study completion, an average of 1 year
Surgery
proportion of patients having undergone epilepsy surgery.
Time frame: 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...
Time frame: 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...
Time frame: through study completion, an average of 1 year
Adjustment of concomitant treatments over the time
continuation without change, change in dosage, discontinuation
Time frame: 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)
Time frame: through study completion, an average of 1 year
status epilepticus in the past
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proportion of patients who presented with status epilepticus
Time frame: through study completion, an average of 1 year
duration of the status epileticus over the time
duration of status epilepticus
Time frame: 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.
Time frame: 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
Time frame: through study completion, an average of 1 year
frequency of the status epileticus over the time
frequency of status epilepticus
Time frame: through study completion, an average of 1 year
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.
Time frame: 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.
Time frame: 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,
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year