Methods of treating developmental disorders with gaboxadol

Abstract

Methods of treating developmental disorders such as Angelman syndrome, Fragile X syndrome, Fragile X-associated tremor/ataxia syndrome (FXTAS), Autistic Spectrum Disorder, Autism, Asperger's syndrome, pervasive developmental disorder, Childhood Disintegrative Disorder, Rett syndrome, Lanau-Kleffner Syndrome, Prader-Willi Syndrome, Tardive Dyskinesia, and/or Williams Syndrome with gaboxadol or a pharmaceutically acceptable salt thereof are provided. The methods provide therapeutic compositions that may be used to improve one or more symptoms of the developmental disorder.

What is claimed is: 
     
         1 . A method of treating Prader-Willi syndrome comprising administering to a patient in need thereof gaboxadol or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The method of  claim 1 , wherein the patient is administered about 1 mg to about 30 mg gaboxadol or a pharmaceutically acceptable salt thereof. 
     
     
         3 . The method of  claim 1 , wherein the patient is administered about 1 mg to about 25 mg gaboxadol or a pharmaceutically acceptable salt thereof. 
     
     
         4 . The method of  claim 1 , wherein the patient is administered about 1 mg to about 15 mg gaboxadol or a pharmaceutically acceptable salt thereof. 
     
     
         5 . The method of  claim 1 , wherein the patient is administered about 1 mg to about 10 mg gaboxadol or a pharmaceutically acceptable salt thereof. 
     
     
         6 . The method of  claim 1 , wherein the in vivo plasma profile of the patient 6 hours after administration of the gaboxadol or pharmaceutically acceptable salt thereof is reduced by more than 50%. 
     
     
         7 . The method of  claim 1 , wherein the AUC 6-12  of the patient 6 hours after administration of the gaboxadol or pharmaceutically acceptable salt thereof is less than 75% of the administered dose. 
     
     
         8 . The method of  claim 1 , wherein the method provides improvement in the patient for more than 8 hours. 
     
     
         9 . The method of  claim 1  wherein the method provides improvement in the patient for at least 12 hours. 
     
     
         10 . The method of  claim 1 , wherein the method provides improvement in at least one symptom selected from the group consisting of ataxia, gait, speech impairment, vocalization, cognition, motor activity, and short attention span 
     
     
         11 . The method of  claim 1  wherein the method provides improvement in the patient for more than 12 hours after administration. 
     
     
         12 . A method of treating Prader-Willi syndrome comprising administering to a patient in need thereof gaboxadol or a pharmaceutically acceptable salt thereof wherein the method provides an in vivo plasma profile comprising a C max  less than about 400 ng/ml. 
     
     
         13 . A method of treating Prader-Willi syndrome comprising administering to a patient in need thereof gaboxadol or a pharmaceutically acceptable salt thereof wherein the method provides an in vivo plasma profile comprising a AUC 6-12  of less than about 900 ng·hr/ml.