Claims for Patent: 10,478,442

Summary for Patent: 10,478,442

Title:	Method for the treatment of Dravet Syndrome
Abstract:	A method of treating and/or preventing Dravet Syndrome in a patient such as a patient previously diagnosed with Dravet Syndrome, by administering an effective dose of fenfluramine or its pharmaceutically acceptable salt to that patient. Dravet Syndrome patients are typically children under the age of 18 and are treated at a preferred dose of less than about 0.5 to about 0.01 mg/kg/day.
Inventor(s):	Ceulemens; Berten (Westmalle, BE), Lagae; Lieven (Oud Heverlee, BE)
Assignee:	THE KATHOLIEKE UNIVERSITEIT LEUVEN (Leuven, BE) UNIVERSITY HOSPITAL ANTWERP (Edegem, BE)
Application Number:	15/429,646
Patent Claims:	1. A method of adjunctive treatment of seizures in a patient diagnosed with Dravet syndrome, comprising: administering to the patient 0.2 mg/kg/day of fenfluramine or a pharmaceutically acceptable salt thereof; and administering to the patient an effective dose of stiripentol or a pharmaceutically acceptable salt thereof to said patient; whereby seizures are ameliorated in the patient. 2. A method of adjunctive treatment of seizures in a patient diagnosed with Dravet syndrome and exhibiting a mutation in a gene, comprising: administering to the patient 0.2 mg/kg/day of fenfluramine or a pharmaceutically acceptable salt thereof; and administering to the patient an effective dose of stiripentol or a pharmaceutically acceptable salt thereof to said patient; whereby seizures are ameliorated in the patient exhibiting the mutation. 3. The method of claim 2, wherein the mutation is in a gene selected from the group consisting of SCN1A, SCN1B, SCN2A, SCN3A, SCN9A, GABRG2, GABRD and PCDH19. 4. A method of adjunctive treatment of seizures, comprising: determining a patient has a mutation in a gene which mutation is associated with Dravet syndrome; administering to the patient determined to have the mutation: (a) 0.2 mg/kg/day of fenfluramine or a pharmaceutically acceptable salt thereof; and (b) an effective dose of stiripentol or a pharmaceutically acceptable salt thereof; whereby seizures are ameliorated in the patient exhibiting the mutation. 5. The method as claimed in claim 4, wherein the mutation is in a gene selected from the group consisting of SCN1A, SCN1B, SCN2A, SCN3A, SCN9A, GABRG2, GABRD and PCDH19. 6. A method of adjunctive treatment of seizures in a patient diagnosed with Dravet syndrome, comprising: administering to the patient an effective dose of fenfluramine or a pharmaceutically acceptable salt thereof, wherein the fenfluramine or pharmaceutically acceptable salt thereof is administered in a dose of 0.5 mg/kg/day to 0.2 mg/kg/day to the patient; and administering to the patient an effective dose of stiripentol or a pharmaceutically acceptable salt thereof to said patient; whereby seizures are ameliorated in the patient.