Composition and Method for Treating Neurological Disease

Abstract

A method of treating a patient with Parkinson's disease is provided. The method comprises orally administering to the patient a first agent comprising levodopa and once-daily, orally administering to the patient a second agent comprising amantadine, or a pharmaceutically acceptable salt thereof. The amount of levodopa administered is reduced by 20% to 80% of the amount required in the absence of amantadine.

What is claimed is: 
     
         1 . A method of treating a patient with Parkinson's disease comprising orally administering to the patient a first agent comprising a therapeutically effective amount of levodopa and once-daily, orally administering to the patient a second agent comprising a therapeutically effective amount of amantadine, or a pharmaceutically acceptable salt thereof, in an amount ranging from 200 to 500 mg in an extended release form, wherein the daily dose of levodopa is reduced by 20% to 80% of the amount required in the absence of amantadine. 
     
     
         2 . The method of  claim 1 , wherein the first agent additionally comprises carbidopa. 
     
     
         3 . The method of  claim 2 , wherein the daily dose of carbidopa is reduced by 20% to 80% of the amount required in the absence of amantadine. 
     
     
         4 . The method of any of  claims 1  to  3 , wherein the amantadine or pharmaceutically acceptable salt thereof provides change in plasma concentration as a function of time (dC/dT) over a defined period between 0 and 4 hours after administration that is less than about 40% of the dC/dT of the same quantity of an immediate release form of amantadine over said defined time period, wherein the dC/dT is measured in a single dose human pharmacokinetic study. 
     
     
         5 . The method of  claim 4 , wherein the amantadine or pharmaceutically acceptable salt thereof provides a shift in Tmax of 4 hours to 16 hours relative to an immediate release form of amantadine, wherein the Tmax is measured in a single dose human pharmacokinetic study. 
     
     
         6 . The method of  claim 5 , wherein the amantadine, or pharmaceutically acceptable salt thereof, is administered in an amount ranging from 300 mg to 500 mg per day. 
     
     
         7 . The method of  claim 4 , wherein the amantadine, or pharmaceutically acceptable salt thereof, is administered in an amount ranging from 300 mg to 500 mg per day. 
     
     
         8 . The method of any of  claims 1  to  3 , wherein the amantadine or pharmaceutically acceptable salt thereof provides a shift in Tmax of 4 hours to 16 hours relative to an immediate release form of amantadine, wherein the Tmax is measured in a single dose human pharmacokinetic study. 
     
     
         9 . The method of  claim 8 , wherein the amantadine, or pharmaceutically acceptable salt thereof, is administered in an amount ranging from 300 mg to 500 mg per day. 
     
     
         10 . The method of any of  claims 1  to  3 , wherein the amantadine, or pharmaceutically acceptable salt thereof, is administered in an amount ranging from 300 mg to 500 mg per day.