Treatment of nocturnal symptoms and morning akinesia in subjects with parkinson's disease

Abstract

Provided are methods and compositions for treating nocturnal symptoms of Parkinson's disease, morning akinesia, or associated symptoms thereof in a human subject in need thereof, wherein circulating plasma levels of levodopa are provided for an extended period of time following a period of delay after administration.

What is claimed: 
     
         1 . A gastroretentive device for treating nocturnal symptoms of Parkinson's disease, morning akinesia, or associated symptoms of morning akinesia, in a human subject having Parkinson's disease, wherein, following oral administration to the subject, circulating plasma levels of levodopa are not identifiable until at least two hours following the administration, and therapeutically effective circulating plasma levels of levodopa are identifiable in the subject for at least five hours. 
     
     
         2 . The gastroretentive device according to  claim 1 , comprising at least 300 mg of levodopa. 
     
     
         3 . The gastroretentive device according to  claim 1 , further comprising a DOPA decarboxylase, a COMT inhibitor, or both. 
     
     
         4 . The gastroretentive device according to  claim 1 , wherein therapeutically effective circulating plasma levels of levodopa of at least 400 ng/ml are identifiable in the subject. 
     
     
         5 . The gastroretentive device according to  claim 1 , wherein therapeutically effective circulating plasma levels of levodopa are not identifiable in the subject until at least three hours after administration. 
     
     
         6 . The gastroretentive device according to  claim 1 , wherein therapeutically effective circulating plasma levels of levodopa are identifiable in the subject about three hours following administration. 
     
     
         7 . The gastroretentive device according to  claim 1 , wherein therapeutically effective circulating plasma levels of levodopa are identifiable in the subject about 8-14 hours following administration. 
     
     
         8 . The gastroretentive device according to  claim 1 , wherein therapeutically effective circulating plasma levels of levodopa are identifiable in the subject for about 6-10 hours. 
     
     
         9 . The gastroretentive device according to  claim 1 , wherein therapeutically effective circulating plasma levels of levodopa are identifiable in the subject for about 7-9 hours. 
     
     
         10 . The gastroretentive device according to  claim 1 , wherein therapeutically effective circulating plasma levels of levodopa are not identifiable in the subject until after midnight when the gastroretentive device is administered together with, or immediately following, consumption of an evening meal by the subject. 
     
     
         11 . The gastroretentive device according to  claim 10 , wherein therapeutically effective circulating plasma levels of levodopa are identifiable in the subject between the hours of 6-8 am.