Methods Of Treating Fragile X Syndrome And Related Disorders

Abstract

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

We claim: 
     
         1 . A method of treating or alleviating a symptom of Fragile X Syndrome or an Autism Spectrum Disorder, comprising administering to a subject having Fragile X Syndrome or an Autism Spectrum Disorder a composition comprising metadoxine. 
     
     
         2 . The method of  claim 1 , comprising administering a total per day dose of metadoxine of between 100-3000 mg. 
     
     
         3 . The method of  claim 1 , wherein the metadoxine is administered daily, every other day or weekly. 
     
     
         4 . The method of  claim 1 , wherein the metadoxine is administered in one, two, or three dosage forms per day. 
     
     
         5 . 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. 
     
     
         6 . 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.   
     
     
         7 . The method of  claim 6 , wherein the relative proportion of the slow release metadoxine to the immediate release metadoxine is about 65:35. 
     
     
         8 . The method of  claim 1 , wherein the symptom is impaired learning or impaired sociability. 
     
     
         9 . The method of  claim 1 , wherein the subject has an Autism Spectrum Disorder.