Methods and composition for treatment of migraine and symptoms thereof

Abstract

Compositions, methods and kits are provided for the treatment of migraines. The compositions, methods and kits include an effective dose of trimethobenzamide and an ethanolamine antihistamine that, when administered to an individual suffering from migraine headaches, will alleviate symptoms associated with the migraine headaches. Compositions, methods, and kits for the treatment of migraines include pharmaceutical compositions of trimethobenzamide and diphenhydramine.

1 . A composition consisting essentially of a therapeutically effective amount of trimethobenzamide and an ethanolamine antihistamine.  
   
   
       2 . The composition of  claim 1 , wherein the antihistamine is doxylamine, diphenhydramine, bromodiphenhydramine, dimenhydrinate, clemastine, bietanautine, carbinoxamine, diphenylpyraline, embramine, medrylamine, moxastine, p-methyldiphenhydramine, orphenadrine, phenyltoloxamine, or setastine.  
   
   
       3 . The composition of  claim 2 , wherein the antihistamine is doxylamine, diphenhydramine, bromodiphenhydramine, dimenhydrinate, bietanautine, carbinoxamine, embramine, medrylamine, moxastine, p-methyldiphenhydramine, orphenadrine, phenyltoloxamine, or setastine.  
   
   
       4 . The composition of  claim 3 , wherein the antihistamine is doxylamine, diphenhydramine, bromodiphenhydramine, or dimenhydrinate.  
   
   
       5 . The composition of  claim 4 , wherein the antihistamine is diphenhydramine.  
   
   
       6 . The composition of  claim 1 , wherein the composition is formulated for non-parenteral delivery.  
   
   
       7 . The composition of  claim 6 , wherein the composition is formulated for oral delivery.  
   
   
       8 . The composition of  claim 1 , wherein the composition is formulated for parenteral delivery.  
   
   
       9 . The composition of  claim 8 , wherein parenteral delivery is via intra venous delivery or injection.  
   
   
       10 . The composition of  claim 9 , wherein the parenteral delivery is via injection.  
   
   
       11 . The composition of  claim 5 , wherein the composition is formulated for injection or oral delivery.  
   
   
       12 . A pharmaceutical composition consisting essentially of a therapeutically effective amount of trimethobenzamide and an ethanolamine antihistamine, wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients, adjuvants, diluents or stabilizers.  
   
   
       13 . The pharmaceutical composition of  claim 12 , wherein the antihistamine is doxylamine, diphenhydramine, bromodiphenhydramine, dimenhydrinate, clemastine, bietanautine, carbinoxamine, diphenylpyraline, embramine, medrylamine, moxastine, p-methyldiphenhydramine, orphenadrine, phenyltoloxamine, or setastine.  
   
   
       14 . The pharmaceutical composition of  claim 13 , wherein the antihistamine is doxylamine, diphenhydramine, bromodiphenhydramine, dimenhydrinate, bietanautine, carbinoxamine, embramine, medrylamine, moxastine, p-methyldiphenhydramine, orphenadrine, phenyltoloxamine, or setastine.  
   
   
       15 . The pharmaceutical composition of  claim 14 , wherein the antihistamine is doxylamine, diphenhydramine, bromodiphenhydramine, or dimenhydrinate.  
   
   
       16 . The pharmaceutical composition of  claim 15 , wherein the antihistamine is diphenhydramine.  
   
   
       17 . The pharmaceutical composition of  claim 12 , wherein the composition is formulated for non-parenteral delivery.  
   
   
       18 . The composition of  claim 17 , wherein the composition is formulated for oral delivery.  
   
   
       19 . The pharmaceutical composition of  claim 12 , wherein the composition is formulated for parenteral delivery.  
   
   
       20 . The pharmaceutical composition of  claim 19 , wherein parenteral delivery is via intra venous delivery or injection.  
   
   
       21 . The pharmaceutical composition of  claim 20 , wherein the parenteral delivery is via injection.  
   
   
       22 . The pharmaceutical composition of  claim 16 , wherein the composition is formulated for injection or oral delivery.  
   
   
       23 . A composition comprising a therapeutically effective amount of trimethobenzamide and diphenhydramine.  
   
   
       24 . The composition of  claim 23 , wherein the composition is formulated for non-parenteral delivery.  
   
   
       25 . The composition of  claim 24 , wherein the composition is formulated for oral delivery.  
   
   
       26 . The composition of  claim 23 , wherein the composition is formulated for parenteral delivery.  
   
   
       27 . The composition of  claim 26 , wherein parenteral delivery is via intra venous delivery or injection.  
   
   
       28 . The composition of  claim 27 , wherein the parenteral delivery is via injection.  
   
   
       29 . A pharmaceutical composition comprising a therapeutically effective amount of trimethobenzamide and diphenhydramine, wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients, adjuvants, diluents or stabilizers.  
   
   
       30 . The pharmaceutical composition of  claim 29 , wherein the composition is formulated for non-parenteral delivery.  
   
   
       31 . The pharmaceutical composition of  claim 30 , wherein the composition is formulated for oral delivery.  
   
   
       32 . The pharmaceutical composition of  claim 29 , wherein the composition is formulated for parenteral delivery.  
   
   
       33 . The pharmaceutical composition of  claim 32 , wherein parenteral delivery is via intra venous delivery or injection.  
   
   
       34 . The pharmaceutical composition of  claim 33 , wherein the parenteral delivery is via injection.  
   
   
       35 . A method for the treatment of migraines comprising administering to an individual in need thereof a unit dose of a composition consisting essentially of trimethobenzamide and an ethanolamine antihistamine.  
   
   
       36 . The method of  claim 35 , wherein the method further comprises the administration of an additional unit dose after a period of time.  
   
   
       37 . The method of  claim 36 , wherein the period of time is at least one month.  
   
   
       38 . The method of  claim 35 , wherein treatment is prophylactic and wherein the unit dose is administered about one time per month.  
   
   
       39 . The method of  claim 35 , wherein the antihistamine is doxylamine, diphenhydramine, bromodiphenhydramine, dimenhydrinate, clemastine, bietanautine, carbinoxamine, diphenylpyraline, embramine, medrylamine, moxastine, p-methyldiphenhydramine, orphenadrine, phenyltoloxamine, or setastine.  
   
   
       40 . The method of  claim 39 , wherein the antihistamine is doxylamine, diphenhydramine, bromodiphenhydramine, dimenhydrinate, bietanautine, carbinoxamine, embramine, medrylamine, moxastine, p-methyldiphenhydramine, orphenadrine, phenyltoloxamine, or setastine.  
   
   
       41 . The method of  claim 40 , wherein the antihistamine is doxylamine, diphenhydramine, bromodiphenhydramine, or dimenhydrinate.  
   
   
       42 . The method of  claim 41 , wherein the antihistamine is diphenhydramine.  
   
   
       43 . The method of  claim 35 , wherein the composition is formulated for non-parenteral delivery.  
   
   
       44 . The method of  claim 43 , wherein the composition is formulated for oral delivery.  
   
   
       45 . The method of  claim 35 , wherein the composition is formulated for parenteral delivery.  
   
   
       46 . The method of  claim 45  wherein parenteral delivery is via intra venous delivery or injection.  
   
   
       47 . The method of  claim 46 , wherein the parenteral delivery is via injection.  
   
   
       48 . The method of  claim 42 , wherein the composition is formulated for injection or oral delivery.  
   
   
       49 . The method of any one of claims  35 ,  42 ,  43  or  45 , wherein the composition is a pharmaceutical composition further comprising one or more pharmaceutically acceptable excipients, adjuvants, diluents or stabilizers.  
   
   
       50 . A method for the treatment of migraines comprising administering to an individual in need thereof a unit dose of a composition comprising trimethobenzamide and diphenhydramine.  
   
   
       51 . The method of  claim 50 , wherein the method further comprises the administration of an additional unit dose after a period of time.  
   
   
       52 . The method of  claim 51 , wherein the period of time is at least one month.  
   
   
       53 . The method of  claim 50 , wherein treatment is prophylactic and wherein the unit dose is administered about one time per month.  
   
   
       54 . The method of  claim 50 , wherein the composition is formulated for non-parenteral delivery.  
   
   
       55 . The method of  claim 54 , wherein the composition is formulated for oral delivery.  
   
   
       56 . The method of  claim 50 , wherein the composition is formulated for parenteral delivery.  
   
   
       57 . The method of  claim 56  wherein parenteral delivery is via intra venous delivery or injection.  
   
   
       58 . The method of  claim 57 , wherein the parenteral delivery is via injection.  
   
   
       59 . The method of any one of claims  50 ,  54  or  56 , wherein the composition is a pharmaceutical composition further comprising one or more pharmaceutically acceptable excipients, adjuvants, diluents or stabilizers.  
   
   
       60 . A kit for the treatment of migraines comprising a pharmaceutical composition consisting essentially of a unit dose of trimethobenzamide and an ethanolamine antihistamine, wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients, adjuvants, diluents or stabilizers.  
   
   
       61 . The kit of  claim 60 , wherein the kit further comprises instructions for use.  
   
   
       62 . The kit of  claim 61 , wherein the pharmaceutical composition is formulated for parenteral delivery.  
   
   
       63 . The kit of  claim 62 , wherein the pharmaceutical composition is formulated for injection and the kit further comprises a syringe.  
   
   
       64 . The kit of  claim 62 , wherein the pharmaceutical composition is formulated for intra venous delivery.  
   
   
       65 . The kit of  claim 61 , wherein the pharmaceutical composition is formulated for non-parenteral delivery.  
   
   
       66 . The kit of  claim 65 , wherein the pharmaceutical composition is formulated for oral delivery.  
   
   
       67 . The kit of any one of claims  60 - 66 , wherein the unit dose of trimethobenzamide and an ethanolamine antihistamine may be formulated as a mixture or may be provided in separate dosage forms, and wherein the kit may comprise one or more unit doses.  
   
   
       68 . The kit of  claim 67 , wherein the unit dose of trimethobenzamide and an ethanolamine antihistamine is formulated as a mixture.  
   
   
       69 . A kit for the treatment of migraines comprising a pharmaceutical composition comprising a unit dose of trimethobenzamide and diphenhydramine, wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients, adjuvants, diluents or stabilizers.  
   
   
       70 . The kit of  claim 69 , wherein the kit further comprises instructions for use.  
   
   
       71 . The kit of  claim 70 , wherein the pharmaceutical composition is formulated for parenteral delivery.  
   
   
       72 . The kit of  claim 71 , wherein the pharmaceutical composition is formulated for injection and the kit further comprises a syringe.  
   
   
       73 . The kit of  claim 71 , wherein the pharmaceutical composition is formulated for intra venous delivery.  
   
   
       74 . The kit of  claim 70 , wherein the pharmaceutical composition is formulated for non-parenteral delivery.  
   
   
       75 . The kit of  claim 74 , wherein the pharmaceutical composition is formulated for oral delivery.  
   
   
       76 . The kit of any one of claims  69 - 75 , wherein the unit dose of trimethobenzamide and dephenhydramine may be formulated as a mixture or may be provided in separate dosage forms, and wherein the kit may comprise one or more unit doses.  
   
   
       77 . The kit of  claim 76 , wherein the unit dose of trimethobenzamide and dephenhydramine is formulated as a mixture.