IP Library › Granted Patent US 12,251,431
Granted Patent B2
US 12,251,431 · App. 17/880,962 · Granted Mar 18, 2025

Botulinum toxin for use in treatment of autism spectrum disorders

Inventor: Roland M. Williams (Beaumont, TX)
Assignee: Penland Foundation
A61K38/4893A61P25/00C12N9/52C12Y304/24069
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Quick Facts
Patent No.
US 12,251,431
App. No.
17/880,962
Granted
Mar 18, 2025
Kind
B2
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 (18)

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 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 is less than or equal to about 150 units.

2. The method of claim 1 , wherein the total dosage is 1-50 units.

3. The method of claim 1 , wherein the total dosage is 1-30 units.

4. The method of claim 1 , wherein a therapeutically effective amount is 1-4 units.

5. The method of claim 1 , wherein a therapeutically effective amount is 2-4 units.

6. 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.

7. 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.

8. 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.

9. The method of claim 1 reduces or eliminates a symptom of ASD in a child over about 5 years old and an adult.

10. The method of claim 1 , wherein each of the subcutaneous or intradermal injections is bilateral.

11. 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.

12. The method of claim 1 , wherein the lumbar nerve is selected from the group consisting of a l-1 nerve, l-2 nerve, l-3 nerve, l-4 nerve, l-5 nerve and a combination thereof.

13. 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.

14. 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.

15. The method of claim 14 , 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.

16. The method of claim 1 further comprises monitoring whether the patient's neuroexcitatory substances levels normalize.

17. The method of claim 16 , wherein the neuroexcitatory substances comprise substance P, CGRP or glutamate.

18. The method of claim 16 further comprises administering a neuroexcitatory substances antagonist if the patient's neuroexcitatory substances levels fail to normalize, wherein the neuroexcitatory substances antagonist is a glutamate antagonist.

Continuity (5)
Continuation 17525367 · Nov 12, 2021
Continuation PCTUS2020056206 · Oct 17, 2020
Continuation 16657933 · Oct 18, 2019
Continuation 16657950 · Oct 18, 2019
Related Publication 20220378885A1 · Dec 1, 2022
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