# US 10,478,441 B2 · Method for the treatment of Dravet syndrome

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,478,441 B2
- Document ID: US10478441B2
- Status: Granted
- Kind: B2
- Application number: 15/429,516
- Filed: 2017-02-10
- Published: 2017-06-01
- Granted: 2019-11-19
- Earliest claimed: 2013-05-03
- Assignees: Katholieke Universiteit Leuven; University Hospital Antwerp
- Applicants: The Katholieke Universiteit Leuven; University Hospital Antwerp
- Inventors: Berten Ceulemens; Lieven Lagae
- Web page: https://patentgrep.com/patent/US10478441B2

## CPC

- A61K 31/5513: 1,4-Benzodiazepines, e.g. diazepam {or clozapine}
- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 31/36: Compounds containing methylenedioxyphenyl groups, e.g. sesamin
- A61K 31/551: having two nitrogen atoms, e.g. dilazep
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/08: Antiepileptics; Anticonvulsants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/156: Polymorphic or mutational markers
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## 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

### Claim 1

A method of stimulating 5-HT receptors in the brain of 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;
whereby 5-HT receptors are stimulated and wherein the 5-HT receptor is in a family of receptors selected from the group consisting of 5-HT1, 5-HT2, 5-HT3, 5-HT4, 5-HT5, 5-HT6, and 5-HT7.

### Claim 2 (depends on 1)

The method of claim 1, wherein the 5-HT receptor is in the 5-HT1 receptor family and is selected from the group consisting of 5-HT1A, 5-HT1B, 5-HT1C, 5-HT1D, 5-HT1E, 5-HT1F.

### Claim 3 (depends on 1)

The method of claim 1, wherein the 5-HT receptor is in the 5-HT2 receptor family and is selected from the group consisting of 5-HT2A, 5-HT2B, 5-HT2C.

### Claim 4 (depends on 1)

The method of claim 1, wherein the 5-HT receptor is the 5-HT3 receptor.

### Claim 5

A method of stimulating 5-HT receptors in the brain of a patient diagnosed with Dravet syndrome, comprising:
administering to the patient an effective dose of fenfluramine or a pharmaceutically acceptable salt thereof 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;
whereby 5-HT receptors are stimulated.

### Claim 6 (depends on 5)

The method of claim 5, wherein the effective dose is administered in the form of one or more dosage forms for oral, injectable, transdermal, inhaled, nasal, rectal, vaginal or parenteral delivery.