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

NACompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Infantile Spasms
Interventions
DRUG

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)."

Trial Locations (12)

13385

Service de neurologie pédiatrique - Hôpital de la Timone, Marseille

33076

Service de neuropédiatrie - CHU Pellegrin Enfants, Bordeaux

35203

Service de neurologie pédiatrique - Hôpital Sud, Rennes

37044

Service de neuropédiatrie - Hôpital de Clocheville, Tours

59037

Service de neurologie infantile - Hôpital Salengro, Lille

67098

Centre référent des épilepsies rares pédiatrique associé - Hôpital de Hautepierre, Strasbourg

69677

Service de nuerologie pédiatrique - Hôpital Femme Mère Enfant, Lyon

75015

Service de neurologie pédiatrique - Hôpital Necker Enfants Malades, Paris

75019

Service de neuropédiatrie - Hôpital Robert Debré, Paris

80054

Service de neurologie pédiatrique - CHU, Amiens

331059

Service de neuropédiatrie - Hôpital Purpan, Toulouse

49033²

Service de neurologie pédiatrique - CHU, Angers

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

collaborator

Hospices Civils de Lyon

OTHER

collaborator

National Research Agency, France

OTHER

lead

Orphelia Pharma

INDUSTRY

NCT02220114 - Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy | Biotech Hunter | Biotech Hunter