Infantile Spasms Clinical Trial
Official title:
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,
- PK parameters,
- 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.
n/a
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