Treatment of Migraine Headaches with Presynaptic Neurotoxin

Abstract

The present invention provides a method for treating a patient for migraine headache, including symptoms associated with migraine headache, such as migraine associated vertigo, which comprises administering to the patient a therapeutically effective amount of an invertebrate presynaptic neurotoxin, e.g. Botulinum toxin in a pharmaceutically safe form.

What is claimed is: 
     
         1 . A method for treating a patient for migraine headache which comprises administering to the patient a therapeutically effective amount of an invertebrate presynaptic neurotoxin in a pharmaceutically safe form, wherein the method comprises the selection and treatment of externally caused migraine headache and said method comprises:
 identifying a patient group having migraine headache;   of the identified patient group, determining a specific patient with a post traumatic migraine headache; and   administering to the selected patient a therapeutically effective amount of an invertebrate presynaptic neurotoxin in a pharmaceutically safe form to the selected patient's head, or   
       the method comprises a method for treating a human patient with migraine headache and said method comprises:
 administering to the patient a therapeutically effective amount of an invertebrate presynaptic neurotoxin in a pharmaceutically safe form; 
 the administration being on the trigeminal cervical system, for enabling transport of the neurotoxin from distal to central sites, said administration comprising extramuscular injection of the neurotoxin over the aponeurotic fascia of the scalp for enabling the neurotoxin to diffuse into distal sensory nerves, in order to enable concentration over the occipital-parietal-frontal head region, or 
 
       the method comprises a method for treating a human patient with migraine headache and said method comprises:
 administering to the patient a therapeutically effective amount of an invertebrate presynaptic neurotoxin in a pharmaceutically safe form; 
 the administration comprising intra-oral extramuscular injection of the neurotoxin in a foramina of the sphenopalatine ganglion for enabling diffusion of the neurotoxin to the ganglion; and 
 the administration being on the trigeminal cervical system, enabling axonal transport of the neurotoxin from distal to central sites, or 
 
       the method comprises a method for treating a human patient with migraine headache and said method comprises:
 administering to the patient a therapeutically effective amount of an invertebrate presynaptic neurotoxin in a pharmaceutically safe form; and 
 the administration comprising extramuscular injection of the neurotoxin to emerging nerve points in the face and neck including foraminal sites for enabling the neurotoxin access to concentrated nerve bundles at exit points of the foramina, or 
 
       the method of comprises a method for reducing the symptoms of migraine associated vertigo comprising administering to a human having migraine associated vertigo a therapeutically effective amount of a presynaptic neurotoxin in a pharmaceutically safe form. 
     
     
         2 . The method of  claim 1  which comprises the selection and treatment of externally caused migraine headache, said method comprising:
 identifying a patient group having migraine headache; 
 of the identified patient group, determining a specific patient with a post traumatic migraine headache; and 
 administering to the selected patient a therapeutically effective amount of an invertebrate presynaptic neurotoxin in a pharmaceutically safe form to the selected patient's head. 
 
     
     
         3 . The method of  claim 1  which comprises a method for treating a human patient with migraine headache, said method comprising:
 administering to the patient a therapeutically effective amount of an invertebrate presynaptic neurotoxin in a pharmaceutically safe form; 
 the administration being on the trigeminal cervical system, for enabling transport of the neurotoxin from distal to central sites, said administration comprising extramuscular injection of the neurotoxin over the aponeurotic fascia of the scalp for enabling the neurotoxin to diffuse into distal sensory nerves, in order to enable concentration over the occipital-parietal-frontal head region. 
 
     
     
         4 . The method of  claim 1  which comprises a method for treating a human patient with migraine headache, said method comprising:
 administering to the patient a therapeutically effective amount of an invertebrate presynaptic neurotoxin in a pharmaceutically safe form; 
 the administration comprising intra-oral extramuscular injection of the neurotoxin in a foramina of the sphenopalatine ganglion for enabling diffusion of the neurotoxin to the ganglion; and 
 the administration being on the trigeminal cervical system, enabling axonal transport of the neurotoxin from distal to central sites. 
 
     
     
         5 . The method of  claim 1  which comprises a method for treating a human patient with migraine headache, said method comprising:
 administering to the patient a therapeutically effective amount of an invertebrate presynaptic neurotoxin in a pharmaceutically safe form; and 
 the administration comprising extramuscular injection of the neurotoxin to emerging nerve points in the face and neck including foraminal sites for enabling the neurotoxin access to concentrated nerve bundles at exit points of the foramina. 
 
     
     
         6 . The method of  claim 1  which comprises a method for reducing the symptoms of migraine associated vertigo comprising administering to a human having migraine associated vertigo a therapeutically effective amount of a presynaptic neurotoxin in a pharmaceutically safe form. 
     
     
         7 . The method of  claim 1  wherein said migraine headache is chronic migraine headache. 
     
     
         8 . The method of  claim 1  wherein the presynaptic neurotoxin is a Botulinum toxin. 
     
     
         9 . The method of  claim 8  wherein the presynaptic neurotoxin is a Botulinum toxin A. 
     
     
         10 . The method of  claim 7  wherein the neurotoxin comprises an Endotoxin. 
     
     
         11 . The method of  claim 10  wherein the Endotoxin is an endopeptidase derived from Botulinum toxin. 
     
     
         12 . The method of  claim 8  wherein the Botulinum toxin is diluted with saline. 
     
     
         13 . The method of  claim 12  wherein the Botulinum toxin is diluted to at least about 1 cc saline per 100 units of Botulinum toxin. 
     
     
         14 . The method according to  claim 1  wherein the externally caused headache is post-traumatic stress disorder (PTSD). 
     
     
         15 . The method according to  claim 1  wherein the externally caused headache is traumatic brain injury (TBI). 
     
     
         16 . The method according to  claim 3  wherein the administration to the aponeurotic fascia includes dilution of about 4 to 10 cc of normal saline per 100 units of Botulinum toxin. 
     
     
         17 . The method according to  claim 2  wherein the invertebrate presynaptic neurotoxin is Botulinum toxin and the administration comprises extramuscular injection of the Botulinum toxin (a) over the aponeurotic fascia to enable the Botulinum toxin to diffuse into distal sensory nerves, in order to concentrate the Botulinum toxin over the occipital-parietal-frontal head region, or (b) intra-orally, in a foramina of the sphenopalatine ganglion for enabling diffusion of the Botulinum toxin to the ganglion, or (c) to emerging exit points of nerves including foraminal sites for enabling the Botulinum toxin access to concentrated nerve bundles at exit points of the foramina. 
     
     
         18 . The method according to  claim 17  wherein the administrations according to (b) and (c) are at a dilution of about 1 cc normal saline per 100 units of Botulinum toxin.