Method for the treatment of Dravet syndrome

• US 9,603,815 B2
• Filed: 01/21/2016
• Issued: 03/28/2017
• Est. Priority Date: 05/03/2013
• Status: Active Grant

• Current Assignee: Katholieke Universiteit Leuven, University Hospital Antwerp
• Original Assignee: Katholieke Universiteit Leuven, University Hospital Antwerp
• Inventors: Ceulemens, Berten, Lagae, Lieven
• Primary Examiner(s): Kantamneni, Shobha
• Application Number:
  US15/003,161
• Publication Number:
  US 20160136114A1
• Time in Patent Office: 432 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/36 Compounds containing methylenedioxyphenyl groups, e.g. sesamin
• CPC Class Codes: A61K 31/551 having two nitrogen atoms, e.g. dilazep
• CPC Class Codes: A61K 31/5513 1,4-Benzodiazepines, e.g. diazepam or clozapine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 2600/156 Polymorphic or mutational markers

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.

Claims

1. A method of treating seizures in a patient diagnosed with Dravet syndrome, comprising:

administering to the patient diagnosed with Dravet Syndrome a therapeutically effective dose of a 5-HT2C agonist;

administering an effective dose of stiripentol or a pharmaceutically acceptable salt thereof to said patient;

administering an effective dose of valproate or a pharmaceutically acceptable salt thereof to said patient;

administering an effective dose of clobazam or a pharmaceutically acceptable salt thereof to said patient; and

allowing the 5-HT2C agonist to stimulate 5-HT2C receptors in the patient and thereby reduce seizures in the patient, wherein the 5-HT2C agonist is fenfluramine.

2. The method of claim 1,

wherein the therapeutically effective dose of fenfluramine is 0.5 mg/kg/day to 0.01 mg/kg/day, and

wherein the patient is aged 18 or less.

3. The method of claim 1, wherein the therapeutically effective dose of fenfluramine is administered in a dosage form selected from the groups consisting of oral, injectable, transdermal, inhaled, nasal, rectal, vaginal and parenteral.