# US 2016/0193199 A1 · Methods of treating fragile x syndrome and related disorders

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

- Number: US 2016/0193199 A1
- Document ID: US20160193199A1
- Status: Published application
- Kind: A1
- Application number: 14/917,169
- Filed: 2014-09-09
- Published: 2016-07-07
- Earliest claimed: 2013-09-09
- Assignees: Alcobra Ltd.
- Applicants: Alcobra Ltd.
- Inventors: Yaron DANIELY; Dalia MEGIDDO
- Web page: https://patentgrep.com/patent/US20160193199A1

## CPC

- G01N 33/573: for enzymes or isoenzymes
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/4015: having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
- A61K 31/4425: Pyridinium derivatives, e.g. pralidoxime, pyridostigmine
- A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465)
- A61P 25/00: Drugs for disorders of the nervous system
- G01N 2333/91205: Phosphotransferases in general
- G01N 2440/14: phosphorylation
- G01N 2800/30: Psychoses; Psychiatry
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- 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

## Abstract

The present invention provides methods of alleviating a sign or a symptom of Fragile X Syndrome and relates disorders such as autism spectrum disorders.

## Claims

### Claim 1

A method of treating or alleviating a symptom of Fragile X Syndrome or a related disorder comprising administering to a subject in need thereof a composition comprising metadoxine.

### Claim 2 (depends on 1)

The method of claim 1, comprising administering a total per day dose-of metadoxine of between 100-3000 mg.

### Claim 3 (depends on 1)

The method of claim 1, wherein the metadoxine is administered daily, every other day or weekly.

### Claim 4 (depends on 1)

The method of claim 1, wherein the metadoxine is administered in one, two, or three dosage forms per day.

### Claim 5 (depends on 1)

The method of claim 1, wherein the metadoxine is administered in a sustained release oral dosage form, wherein the metadoxine is formulated as a combination of slow release and immediate release forms.

### Claim 6 (depends on 5)

The method of claim 5, wherein:
(a) the slow release form provides for sustained release of the metadoxine for at least 8 hours, and
(b) wherein relative proportion of the slow release metadoxine to the immediate release metadoxine is between about-60:40 and 80:20

### Claim 7 (depends on 6)

The method of claim 6, wherein the relative proportion of the slow release metadoxine to the immediate release metadoxine is about 65:35.

### Claim 8 (depends on 1)

The method of claim 1, wherein the symptom is impaired learning or impaired sociability.

### Claim 9 (depends on 1)

The method of claim 1, wherein the subject has Fragile X Syndrome or an Autism Spectrum Disorder.

### Claim 10 (depends on 1)

The method of claim 1, wherein the related disorder is an Autism Spectrum Disorder.