Last updated on April 2018

Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy

Brief description of 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.

Clinical Study Identifier: NCT02220114

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Service de neurologie p diatrique - CHU
Amiens, France

Sylvie N'GUYEN

Service de neurologie p diatrique - CHU
Angers, France


Service de neurop diatrie - CHU Pellegrin Enfants
Bordeaux, France


Service de neurologie infantile - H pital Salengro
Lille, France

Dorothée VILLE

Service de nuerologie p diatrique - H pital Femme M re Enfant
Lyon, France


Service de neurologie p diatrique - H pital de la Timone
Marseille, France


Service de neurologie p diatrique - H pital Necker Enfants Malades
Paris, France

Stephane AUVIN

Service de neurop diatrie - H pital Robert Debr
Paris, France


Service de neurologie p diatrique - H pital Sud
Rennes, France


Centre r f rent des pilepsies rares p diatrique associ - H pital de Hautepierre
Strasbourg, France


Service de neurop diatrie - H pital Purpan
Toulouse, France

Marie-Anne BARTHEZ

Service de neurop diatrie - H pital de Clocheville
Tours, France