Headache treatment method

Abstract

Herein disclosed are methods for treating headache, such as a chronic migraine for example, by administration of botulinum toxin to fixed specific locations of a patient at a fixed amount, as well as optionally administering additional botulinum toxin to a subset of the fixed specific locations of a patient to treat the headache.

1 . A method for treating migraine headache in a patient in need thereof, consisting essentially of:
 (a) selecting thirty one administration sites for administration of a  botulinum  toxin to head/neck areas of the patient, wherein the thirty one administration sites are   (i) four sites of the frontalis,   (ii) two sites of the corrugator,   (iii) one site to the procerus,   (iv) six sites of the occipitalis,   (v) eight sites of the temporalis,   (vi) six sites of the trapezius and   (vii) four sites of the cervical paraspinal,   wherein the selected sites in step (a) to the frontalis, corrugator, occipitalis, temporalis, trapezius and cervical paraspinal muscles are bilaterally distributed with half the number of sites being to the left side and half the number of sites being to the right side of the patient;   (b) optionally selecting additional sites of administration based upon patient-specific symptoms;   wherein additional sites of administration of step (b) are selected from the group consisting of (i) from zero to two additional sites of administration to the temporalis, (ii) from zero to two additional sites of administration to the occipitalis and (ii) from zero to four additional sites of administration to the trapezius muscles are optionally selected; and   (c) administering five units of the  botulinum  toxin to each of the selected sites, wherein a total amount of  botulinum  toxin administered is from about one hundred fifty-five units to about one hundred ninety-five units, to thereby treat the migraine headache of the patient.   
     
     
         2 . The method of  claim 1 , wherein no step (b) additional sites of administration are selected. 
     
     
         3 . The method of  claim 1 , wherein at least one step (b) additional site of administration is selected. 
     
     
         4 . The method of  claim 1 , wherein at least two step (b) additional sites of administration are selected and are administered to at least two of the temporalis, occipitalis or trapezius. 
     
     
         5 . The method of  claim 1 , wherein each of the temporalis, occipitalis and trapezius has at least one step (b) additional site of administration selected. 
     
     
         6 . The method of step  1 , wherein the  botulinum  toxin is  botulinum  toxin type A. 
     
     
         7 . The method of  claim 1 , wherein all step (b) additional sites of administration are selected. 
     
     
         8 . The method of  claim 1 , wherein the patient suffers from headache for at least 15 days out of a 28 day period. 
     
     
         9 . The method of  claim 1 , wherein the  botulinum  toxin is administered to the patient about every twelve weeks. 
     
     
         10 . The method of  claim 1 , wherein the  botulinum  toxin is administered transdermally, subcutaneously, intramuscularly or intradermally. 
     
     
         11 . A method for treating migraine in a patient in need thereof, the method comprising:
 administering a therapeutically effective amount of a  botulinum  toxin bilaterally to the frontalis at four sites of injection; bilaterally to the corrugator at two sites of injection; to the procerus at one site of injection, bilaterally to the occipitalis at a minimum of six sites of injection, and up to a maximum of eight sites of injection; bilaterally to the temporalis at a minimum of eight sites of injection, and up to a maximum of ten sites of injection; bilaterally to the trapezius at a minimum of six sites of injection, and up to a maximum of ten sites of injection; and bilaterally to the cervical paraspinal muscles at four sites of injection, to thereby treat the migraine of the patient.   
     
     
         12 . The method of  claim 11 , wherein the  botulinum  toxin is selected from the group consisting of  botulinum  toxin type A, B, C, D, E, F and G. 
     
     
         13 . The method of  claim 11 , wherein the  botulinum  toxin is  botulinum  toxin type A. 
     
     
         14 . The method of  claim 11 , wherein the  botulinum  toxin is  botulinum  toxin type A and is administered:
 (a) in an amount of at least twenty units divided evenly among the frontalis four sites of injection;   (b) in an amount of at least ten units divided evenly among the corrugator two sites of injection;   (c) in an amount of at least five units to the procerus at one site of injection;   (d) in an amount of at least thirty units divided evenly among the occipitalis minimum six sites of injection;   (e) in an amount of at least forty units divided evenly among the temporalis minimum eight sites of injection;   (f) in an amount of at least thirty units divided evenly among the trapezius minimum six sites injection; and   (f) in an amount of at least twenty units divided evenly among the cervical paraspinal four sites of injection.   
     
     
         15 . The method of  claim 11 , wherein the patient suffers from headache for at least 15 days out of a 28 day period. 
     
     
         16 . The method of  claim 11 , wherein at least about one hundred and fifty five units of  botulinum  toxin is administered. 
     
     
         17 . A method for treating a migraine in a patient in need thereof, the method comprising the step of administering a minimum amount of a  botulinum  toxin to the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscles of the patient in accordance with the minimum amount of  botulinum  toxin specified in a package insert; and, optionally, administering an additional variable amount of  botulinum  toxin to a subset of the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscles of the patient such that the total amount of  botulinum  toxin administered to the patient does not exceed a maximum total amount specified in the package insert. 
     
     
         18 . The method of  claim 17 , wherein the optional additional variable amount of  botulinum  toxin is administered to at least one of the temporalis, occipitalis and trapezius muscles of the patient. 
     
     
         19 . The method of  claim 17 , wherein the  botulinum  toxin is selected from the group consisting of  botulinum  toxin type A, B, C, D, E, F and G. 
     
     
         20 . The method of  claim 17 , wherein the  botulinum  toxin is  botulinum  toxin type A or  botulinum  toxin type B.