HEADACHE TREATMENT METHOD
First Claim
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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.
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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.
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Citations
20 Claims
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1. A method for treating migraine headache in a patient in need thereof, consisting essentially of:
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(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. - View Dependent Claims (2, 3, 4, 5, 7, 8, 9, 10)
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6. The method of step 1, wherein the botulinum toxin is botulinum toxin type A.
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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.- View Dependent Claims (12, 13, 14, 15, 16)
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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.
- View Dependent Claims (18, 19, 20)
Specification