Antiepileptic
Conditions
Interventions
Trade Name: DIACOMIT
Product Name: DIACOMIT
Pharmaceutical Form: Capsule, hard
Trade Name: DIACOMIT
Product Name: DIACOMIT
Pharmaceutical Form: Powder for oral suspension
Sponsors
BIOCODEX
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female children aged 6 months to 18 years. - Confirmed diagnosis of SMEI (Dravet’s Syndrome). - Patients likely to comply with all study related procedures. - Written consent form signed by both parents (or by child’s legal guardian if applicable). Consent form should also be signed by the child if he/she is able to understand the study procedures. - For patients treated with stiripentol at inclusion: Treatment by stiripentol at the dosage currently prescribed i.e. around 50 mg/kg/day (the total daily dosage being administered in 2 divided doses) associated with valproate and clobazam without any change in daily dosage for at least one week. - For naïve patients for stiripentol: Treatment with valproate and clobazam for at least 4 weeks without any change in daily dosage for at least one week. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients living outside France. - Parents who show tendency to self-medication. - Treated with oral anti-coagulants. - Patients who have been treated in the last 4 weeks with any other AEDs, with the exception of clonazepam and diazepam if used to treat epileptic crisis. - Patients treated with medications known as inhibitors of the CYP3A4 (macrolides, azol antifungal agents). - Patients with known or suspected hypersensitivity reactions to either stiripentol, valproate or clobazam or to one of the excipients of the drugs containing these active substances as described in their SmPCs. - Ongoing pregnancy in a female patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Evaluate the steady state population pharmacokinetic parameters of stiripentol in children with Dravet’s Syndrome treated with stiripentol + valproate + clobazam ;Secondary Objective: - Evaluate the influence of age, weight, sex and co-medications on the pharmacokinetic parameters of stiripentol - Evaluate the population pharmacokinetics of valproate and clobazam co-administrated with stiripentol - To evaluate the influence of genetic polymorphisms of CYP 2C19 on the efficacy and safety of stiripentol. ;Primary end point(s): Pharmacokinetic parameters | — |
Countries
France
Outcome results
None listed