# US 11,439,694 B2 · Botulinum toxin for use in treatment of autism spectrum disorders > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,694 B2 - Document ID: US11439694B2 - Status: Granted - Kind: B2 - Application number: 17/525,367 - Filed: 2021-11-12 - Published: 2022-04-21 - Granted: 2022-09-13 - Earliest claimed: 2019-10-18 - Assignees: Penland Foundation - Applicants: Penland Foundation - Inventors: Roland M. Williams - Web page: https://patentgrep.com/patent/US11439694B2 ## CPC - A61K 38/4893: {Botulinum neurotoxin (3.4.24.69)} - A61P 25/00: Drugs for disorders of the nervous system - C12N 9/52: derived from bacteria {or Archaea} - C12Y 304/24069: Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin - Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - C12Y: ENZYMES - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract A method of treating ASD (autism) in a patient in need thereof comprises administering a botulinum toxin to the patient. The botulinum toxin may be administered by subcutaneous/intradermal injection. The subcutaneous/intradermal injection may be administered to and/or around the vicinity of a trigeminal nerve, a cervical nerve, a thoracic nerve, a lumbar nerve, and a sacral nerve of the patient. In infants or toddlers—from about 1 to 5 year old, it is used to prevent or minimize damage to the developing brain; in older children and adult Autism Spectrum Disorder (ASD) patients, it will be used to reduce or eliminate their symptoms. ## Claims ### Claim 1 A method of treating autism spectrum disorder (ASD) in a patient in need thereof, comprising administering a botulinum toxin to the patient, thereby treating autism spectrum disorder (ASD) wherein the patient is administered by subcutaneous or intradermal injection, 1-4 units to and/or around the vicinity of a trigeminal nerve, 1-4 units to and/or around the vicinity of a cervical nerve, lateral to the patient's spine, 1-4 units to and/or around the vicinity of a thoracic nerve, lateral to the spine, 1-4 units to and/or around the vicinity of a lumbar nerve, lateral to the spine, and/or 1-4 units to and/or around the vicinity of a sacral nerve, lateral to the spine, wherein a total dosage of the botulinum toxin in an adult who weighs about 150 lbs is less than or equal to about 150 units, and the total dosage of the botulinum toxin in an adult is adjusted for weight, and wherein a total dosage of the botulinum toxin in a child over about 5 years old and a toddler about from 1 to 5 years old is adjusted for age, weight or a combination thereof. ### Claim 2 (depends on 1) The method of claim 1, wherein the total dosage is a therapeutically effective amount of botulinum toxin. ### Claim 3 (depends on 2) The method of claim 2, wherein the therapeutically effective amount is 1-50 units. ### Claim 4 (depends on 3) The method of claim 3, wherein the therapeutically effective amount is 1-30 units. ### Claim 5 (depends on 4) The method of claim 4, wherein the therapeutically effective amount is 1-4 units. ### Claim 6 (depends on 5) The method of claim 5, wherein the therapeutically effective amount is 2-4 units. ### Claim 7 (depends on 1) The method of claim 1, wherein the trigeminal nerve is selected from the group consisting of an ophthalmic nerve, maxillary nerve, mandibular nerve, supra orbital nerve, supra trochlear nerve, infraorbital nerve, lacrimal nerve, nasociliary nerve, superior alveolar nerve, buccal nerve, lingual nerve, inferior alveolar nerve, mental nerve, an auriculotemporal nerve, lesser occipital nerve, a greater occipital nerve and a combination thereof. ### Claim 8 (depends on 1) The method of claim 1, wherein the cervical nerve is selected from the group consisting of a c-2 nerve, c-3 nerve, c-4 nerve, c-5 nerve, c-6 nerve, c-7 nerve, c-8 nerve and a combination thereof. ### Claim 9 (depends on 1) The method of claim 1, wherein the botulinum toxin is selected from the group consisting of botulinum toxin type A, botulinum toxin type B, botulinum toxin type C, botulinum toxin type D, botulinum toxin type E, botulinum toxin type F and botulinum toxin type G, a fragment thereof, a hybrid thereof, a chimera thereof, and a combination thereof. ### Claim 10 (depends on 1) The method of claim 1 reduces or eliminates a symptom of autism spectrum disorder (ASD) in a child over about 5 years old and an adult. ### Claim 11 (depends on 1) The method of claim 1, wherein each of the subcutaneous or intradermal injections is bilateral. ### Claim 12 (depends on 1) The method of claim 1, wherein the thoracic nerve is selected from the group consisting of a t-2 nerve, t-3 nerve, t-5 nerve, t-6 nerve, t-7 nerve, t-8 nerve, t-9 nerve, t-10 nerve, t-11 nerve, t-12 nerve and a combination thereof. ### Claim 13 (depends on 1) The method of claim 1, wherein the lumbar nerve is selected from the group consisting of a 1-1 nerve, 1-2 nerve, 1-3 nerve, 1-4 nerve, 1-5 nerve and a combination thereof. ### Claim 14 (depends on 1) The method of claim 1, wherein the sacral nerve is selected from the group consisting of a s-1 nerve, s-2 nerve, s-3 nerve, s-4 nerve, s-5 nerve and a combination thereof. ### Claim 15 (depends on 1) The method of claim 1 further comprises monitoring developmental milestones and/or physical symptoms if the patient is a toddler about from 1 to 5 years old. ### Claim 16 (depends on 15) The method of claim 15, wherein the physical symptoms comprise light sensitivity, dilated pupils, sensitivity to loud noises, sleep disturbances, hyperactivity, sensitivity to touch, depression, anxiety, stomach issues or a combination thereof. ### Claim 17 (depends on 1) The method of claim 1, further comprising monitoring whether the patient's neuroexcitatory substance levels normalize. ### Claim 18 (depends on 17) The method of claim 17, wherein the neuroexcitatory substance is substance P, CGRP, glutamate, or mixtures thereof.