Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy
Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy. Observational, Descriptive, Open-label, Multi-centric, Non-randomized Study
The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required.
This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include:
evaluation of the palatability and user-friendliness of the new treatment,
evaluation of the pharmacokinetic parameters of the new formulation,
evaluation of the tolerance,
measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.
first "treatment" phase (V1/D1-V3/D84), in which patients already under Sabril® "granules for oral solution" and naive patients start the new ST formulation; patients already under Sabril® will start at the same dose and regimen as their usual Sabril®. Dose and regimen for naive patients will be chosen according to SPC. second "treatment" phase (V3/D84-V4/D98) in which the patient is switched to Sabril® "granules for oral solution" (supplied by sponsor) for 15 days at the same dose as under the new ST formulation. Dose and treatment regimen should be maintained as in first treatment phase. - At V4/D98, patients who received Sabril® "granules for oral solution" (supplied by sponsor) continue with marketed Sabril® treatment (or switches to another AED, according to the natural evolution of the patient's condition and upon investigator decision).
Sabril®: sachet for oral solution 500 mg, 50 to 100mg/Kg/day, twice a day, 14 days. Vigabatrin new ST formulation: Soluble tablets 100 or 500 mg, 50 to 100mg/Kg/day, twice a day, 12 weeks.
Inclusion Criteria: Patients with diagnosed infantile spasms (IS) or pharmacoresistant partial onset seizures (POS). Infants > 1 month and < 6 months; infants > 6 months and < 2 years; and children > 2 years and < 6 years. Patients under Sabril® or naive patients. Patients under a twice-a-day posology of Sabril® or patients for whom vigabatrin will be given twice daily. Non inclusion Criteria: Use of more than 2 other antiepileptic drugs as concomitant treatment (including steroids). Ketogenic diet can be in addition to these 2 other antiepileptic drugs. Subjects receiving vigabatrin through a gastric tube. Weight < 1.750 Kgs. Any planned major surgery within the duration of the trial. Participation in any other clinical trial within 3 months prior to V1.