38
Participants
Start Date
May 31, 2014
Primary Completion Date
December 31, 2016
Study Completion Date
December 31, 2016
Vigabatrin: Vigabatrin new ST formulation then Sabril®
"* 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)."
Service de neurologie pédiatrique - Hôpital de la Timone, Marseille
Service de neuropédiatrie - CHU Pellegrin Enfants, Bordeaux
Service de neurologie pédiatrique - Hôpital Sud, Rennes
Service de neuropédiatrie - Hôpital de Clocheville, Tours
Service de neurologie infantile - Hôpital Salengro, Lille
Centre référent des épilepsies rares pédiatrique associé - Hôpital de Hautepierre, Strasbourg
Service de nuerologie pédiatrique - Hôpital Femme Mère Enfant, Lyon
Service de neurologie pédiatrique - Hôpital Necker Enfants Malades, Paris
Service de neuropédiatrie - Hôpital Robert Debré, Paris
Service de neurologie pédiatrique - CHU, Amiens
Service de neuropédiatrie - Hôpital Purpan, Toulouse
Service de neurologie pédiatrique - CHU, Angers
Lead Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Hospices Civils de Lyon
OTHER
National Research Agency, France
OTHER
Orphelia Pharma
INDUSTRY