METHODS OF TREATING DEVELOPMENTAL DISORDERS WITH GABOXADOL
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.
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.