Injection paradigm for administration of botulinum toxins

Abstract

Disorders such as headaches can be treated by administration of a botulinum toxin to a patient suffering therefrom, such as a migraine headache. A combined a fixed site/fixed dose and an optional follow the pain variable dosage and injection site paradigm is disclosed for optimizing clinical effectiveness of botulinum toxin administration for patients suffering headache, particularly chronic migraine.

1 . A method for treating or reducing the occurrence of a headache in a patient in need thereof, the method comprising:
 local administration of a botulinum neurotoxin to 31 fixed injection sites across seven head and neck muscles, and optionally up to 8 additional injection sites into three specific muscles, wherein these three muscles are subset of the seven head and neck muscles,   wherein the 31 fixed injection sites comprise the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscles; and   wherein the administration is by injection and comprises injecting superficially at a 90° angle into the corrugator muscles; thereby alleviating or reducing the occurrence of the headache in the patient; to thereby treat or reduce the occurrence of headache in the patient.   
     
     
         2 . The method of  claim 1 , wherein the headache is a migraine headache. 
     
     
         3 . The method of  claim 1 , wherein the headache is a chronic migraine headache. 
     
     
         4 . The method of  claim 1 , wherein the headache is a medication overuse (MOU) headache. 
     
     
         5 . The method of  claim 1 , wherein the botulinum neurotoxin is serotype A. 
     
     
         6 . The method of  claim 5 , wherein the botulinum neurotoxin type A is onabotulinumtoxinA, 
     
     
         7 . The method of  claim 1 , wherein the total amount of botulinum toxin administered is from about 155 units to about 195 units of onabotulinumtoxinA. 
     
     
         8 . The method of  claim 5 , wherein the botulinum neurotoxin type A is abobotulinumtoxinA. 
     
     
         9 . The method of  claim 1 , wherein the botulinum neurotoxin is a pure botulinum toxin. 
     
     
         10 . The method of  claim 9 , wherein the pure botulinum neurotoxin is incobotulinumtoxinA. 
     
     
         11 . The method of  claim 1 , wherein the botulinum neurotoxin is serotype B. 
     
     
         12 . The method of  claim 11 , wherein the botulinum neurotoxin is type E. 
     
     
         13 . A method for alleviating or reducing the occurrence of a headache in a patient in need thereof, the method comprises:
 localizing one or more administration targets;   isolating the one or more administration targets; wherein the isolating step isolates the one or more administration targets from an adjacent area;   administering a therapeutically effective amount of a clostridial toxin to the one or more isolated administration targets;   wherein the one or more administration targets comprises the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscles;   wherein the administrating step is by injection and wherein the administering step comprises injecting superficially at a 90° angle into the corrugator muscles; thereby alleviating or reducing the occurrence of the headache in the patient.   
     
     
         14 . The method of  claim 13 , wherein the headache is a migraine headache. 
     
     
         15 . The method of  claim 13 , wherein the headache is a chronic migraine headache. 
     
     
         16 . The method of  claim 13 , wherein the headache is a medication overuse (MOU) headache. 
     
     
         17 . The method of  claim 13 , wherein the clostridial toxin is a botulinum toxin. 
     
     
         18 . The method of  claim 17 , wherein the botulinum toxin is type A. 
     
     
         19 . The method of  claim 18 , wherein the botulinum neurotoxin type A is onabotulinumtoxinA, 
     
     
         20 . The method of  claim 17 , wherein the total amount of botulinum toxin administered is from about 155 units to about 195 units of onabotulinumtoxinA. 
     
     
         21 . The method of  claim 18 , wherein the botulinum neurotoxin type A is abobotulinumtoxinA. 
     
     
         22 . The method of  claim 5 , wherein the botulinum neurotoxin is a pure botulinum toxin. 
     
     
         23 . The method of  claim 17 , wherein the pure botulinum neurotoxin is incobotulinumtoxinA. 
     
     
         24 . The method of  claim 17 , wherein the botulinum neurotoxin is serotype B. 
     
     
         25 . The method of  claim 17 , wherein the botulinum neurotoxin is type E.