Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study.
- Conditions
- Antiepileptic
- Registration Number
- EUCTR2007-001784-30-FR
- Lead Sponsor
- BIOCODEX
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - Evaluate the steady state population pharmacokinetic parameters of stiripentol in children with Dravet’s Syndrome treated with stiripentol + valproate + clobazam<br>;Secondary Objective: - Evaluate the influence of age, weight, sex and co-medications on the pharmacokinetic parameters of stiripentol<br>- Evaluate the population pharmacokinetics of valproate and clobazam co-administrated with stiripentol<br>- To evaluate the influence of genetic polymorphisms of CYP 2C19 on the efficacy and safety of stiripentol.<br>;Primary end point(s): Pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method