Method for treatment of parkinson's disease

Abstract

Disclosed is a method for the treatment of a neurological or movement disorder, e.g., Parkinson's disease, in an individual in need thereof, by parenteral administration of levodopa and a dopa decarboxylase inhibitor (DDCI), such as carbidopa, benserazide or any combination thereof, concomitantly with oral administration of levodopa, a DDCI, such as carbidopa, benserazide, or any combination thereof.

1 . A method for treatment of a neurological or movement disorder in a patient in need thereof, said method comprising:
 parenterally administering to the patient a first pharmaceutical composition comprising:
 a) levodopa, a levodopa salt, a levodopa prodrug, or any combination thereof; and 
 b) a dopa decarboxylase inhibitor (DDCI), a DDCI salt, a DDCI prodrug, or any combination thereof; 
   
       and, concomitantly,
 orally administering to the patient a second pharmaceutical composition comprising an active agent selected from the group consisting of levodopa, a levodopa salt, a levodopa prodrug, a dopa decarboxylase inhibitor (DDCI), a DDCI salt, a DDCI prodrug, and any combination thereof. 
 
     
     
         2 . The method according to  claim 1 , wherein the DDCI is carbidopa, benserazide or any combination thereof. 
     
     
         3 . The method according to  claim 1 , wherein the DDCI is the first pharmaceutical composition is the same as the DDCI in the second pharmaceutical composition. 
     
     
         4 . The method according to  claim 1 , wherein the DDCI is the first pharmaceutical composition is different from the DDCI in the second pharmaceutical composition. 
     
     
         5 . The method according to  claim 1 , wherein the second pharmaceutical composition comprises levodopa and a DDCI. 
     
     
         6 . The method according to  claim 1 , wherein the DDCI is carbidopa. 
     
     
         7 . The method according to  claim 1 , wherein said first pharmaceutical composition is administered subcutaneously, transdermally, intradermally, intravenously, intramuscularly, intratracheally, intranasally, intrathecally, intragastrically or intraduodenally. 
     
     
         8 . The method according to  claim 1 , wherein said first pharmaceutical composition is administered subcutaneously. 
     
     
         9 . The method according to  claim 1 , wherein said first pharmaceutical composition is administered to said patient in need thereof via one or more sites. 
     
     
         10 . The method according to  claim 1 , wherein said neurological or movement disorder is Parkinson's disease; secondary parkinsonism, such as drug-induced secondary parkinsonism, neuroleptic induced parkinsonism, postencephalitic parkinsonism, and vascular parkinsonism; motor fluctuations; neurodegenerative disorders; dyskinesia; reduced dopamine levels in the brain; levodopa induced dyskinesia; rapid eye movement sleep behavior disorder (RBD); dystonia; morning akinesia; tremor symptoms, such as essential tremor and drug-induced tremor; myoclonus; chorea, such as drug induced chorea; tics, such as drug induced tics and organic tics; drug induced movement disorder; drug induced akathisia; restless legs syndrome (RLS); stiff-man syndrome; benign shuddering attacks; malignant neuroleptic syndrome; Huntington's disease; Shy-Drager syndrome; brain injury induced conditions, such as carbon monoxide or manganese intoxication; or any combination thereof. 
     
     
         11 . The method according to  claim 1 , wherein said first pharmaceutical composition is administered substantially continuously. 
     
     
         12 . The method according to  claim 1 , wherein said second pharmaceutical composition is administered 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 times a day. 
     
     
         13 . The method according to  claim 1 , wherein said second pharmaceutical composition is administered when symptoms from said neurological or movement disorder require said administration. 
     
     
         14 . The method according to  claim 1 , wherein the second pharmaceutical composition is administered at predefined times, predefined intervals, or both. 
     
     
         15 . The method according to  claim 1 , wherein the second pharmaceutical composition is administered more than once, wherein the administered dose is the same at all administrations. 
     
     
         16 . The method according to  claim 1 , wherein the second pharmaceutical composition is administered more than once, wherein the administered dose differs in at least two administrations. 
     
     
         17 . The method according to  claim 1 , wherein the second pharmaceutical composition is administered in a dose of between about 25 mg levodopa and about 400 mg levodopa, in each administration. 
     
     
         18 - 20 . (canceled) 
     
     
         21 . The method according to  claim 1 , wherein the first pharmaceutical composition comprises levodopa, carbidopa, and a base selected from the group consisting of arginine, NaOH, tris(hydroxymethyl)aminomethane (TRIS), and any combination thereof. 
     
     
         22 . The method according to  claim 1 , wherein the first pharmaceutical composition has a pH in the range of between about 6 to about 10, in the range of between about 8 to about 10, in the range of between about 9 to about 10, in the range of between about 9.1 to about 9.8, or about 9.5. 
     
     
         23 . The method according to  claim 1 , wherein the first pharmaceutical composition comprises between about 1% w/v and about 40% w/v, between about 1% w/v and about 20% w/v, between about 1% w/v and about 10% w/v, between about 2% w/v and about 8% w/v, between about 4% w/v and about 8% w/v, between about 5% w/v and about 7% w/v, or about 6% w/v of levodopa, a levodopa prodrug, a levodopa salt, or any combination thereof. 
     
     
         24 - 55 . (canceled)