IP Library › Granted Patent US 10,960,061
Granted Patent B1
US 10,960,061 · App. 16/875,947 · Granted Mar 30, 2021

Treatment of amyotrophic lateral sclerosis using botulinum toxin

Inventor: Roland M. Williams (Beaumont, TX)
Assignee: PENLAND FOUNDATION
A61K38/4893A61K9/0019C12Y304/24069
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Quick Facts
Patent No.
US 10,960,061
App. No.
16/875,947
Granted
Mar 30, 2021
Kind
B1
Abstract

A method for treating Amyotrophic Lateral Sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig's disease, in a patient in need thereof comprises administering botulinum toxin to the patient. The botulinum toxin may be administered by subcutaneous or intradermal injection. The injection may be administered to and/or around the vicinity of a trigeminal nerve, a cervical nerve, a thoracic nerve, a lumbar nerve, and/or a sacral nerve of the patient. The administration of the botulinum toxin prevents an overproduction of glutamate, Substance P, and CGRP in a sensory system and thereby inhibits a migration of the glutamate, Substance P, and CGRP to the motor system, which otherwise would cause neuroexcitatory toxicity that results in the death of motor neurons.

Claims (19)

1. A method for treating Amyotrophic Lateral Sclerosis (ALS) in a patient in need thereof, comprising administering botulinum toxin to the patient, thereby treating the Amyotrophic Lateral Sclerosis (ALS), wherein the administering for an adult comprises, by subcutaneous or intradermal injection, injecting 2-4 units to and/or around the vicinity of a trigeminal nerve, 2-4 units to and/or around the vicinity of a cervical nerve, lateral to the patient's spine, 2-4 units to and/or around the vicinity of a thoracic nerve, lateral to the patient's spine, 2-4 units to and/or around the vicinity of a lumbar nerve, lateral to the patient's spine, and/or 2-4 units to and/or around the vicinity of a sacral nerve, lateral to the patient's spine.

2. The method of claim 1 , wherein the trigeminal nerve comprises an ophthalmic nerve, maxillary nerve, mandibular nerve, supraorbital nerve, supratrochlear 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, or a combination thereof.

3. The method of claim 1 , wherein the cervical nerve comprises a c-2 nerve, c-3 nerve, c-4 nerve, c-5 nerve, c-6 nerve, c-7 nerve, c-8 nerve, or a combination thereof.

4. The method of claim 1 , wherein the thoracic nerve comprises 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, or a combination thereof.

5. The method of claim 1 , wherein the lumbar nerve comprises an 1-1 nerve, 1-2 nerve, 1-3 nerve, 1-4 nerve, 1-5 nerve, or a combination thereof.

6. The method of claim 1 , wherein the sacral nerve comprises an s-1 nerve, s-2 nerve, s-3 nerve, s-4 nerve, s-5 nerve, or a combination thereof.

7. The method of claim 1 , wherein the administered botulinum toxin comprises botulinum toxin type A, botulinum toxin type B, botulinum toxin type C, botulinum toxin type D, botulinum toxin type E, botulinum toxin type F, botulinum toxin type G, a fragment thereof, a hybrid thereof, a chimera thereof, or a combination thereof.

8. The method of claim 1 , wherein each of the subcutaneous or intradermal injection is bilateral.

9. The method of claim 1 , wherein a total dosage of the botulinum toxin for an adult who weighs about 150 lbs is between about 2 units and about 150 units.

10. The method of claim 1 , wherein a total dosage of the botulinum toxin for an adult, a child is adjusted for age, weight, or a combination thereof.

11. A method for treating Amyotrophic Lateral Sclerosis (ALS) in a patient in need thereof, comprising administering botulinum toxin to the patient, thereby treating the Amyotrophic Lateral Sclerosis (ALS), wherein the administering for an adult comprises, by subcutaneous or intradermal injection, injecting 2-4 units to and/or around the vicinity of a trigeminal nerve, 2-4 units to and/or around the vicinity of a cervical nerve, lateral to the patient's spine, 2-4 units to and/or around the vicinity of a thoracic nerve, lateral to the patient's spine, 2-4 units to and/or around the vicinity of a lumbar nerve, lateral to the patient's spine, and/or 2-4 units to and/or around the vicinity of a sacral nerve, lateral to the patient's spine,

wherein a maximum total dosage of the botulinum toxin is 150 units.

12. The method of claim 11 , wherein the trigeminal nerve comprises an ophthalmic nerve, maxillary nerve, mandibular nerve, supraorbital nerve, supratrochlear 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, or a combination thereof.

13. The method of claim 11 , wherein the cervical nerve comprises a c-2 nerve, c-3 nerve, c-4 nerve, c-5 nerve, c-6 nerve, c-7 nerve, c-8 nerve, or a combination thereof.

14. The method of claim 11 , wherein the thoracic nerve comprises 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, or a combination thereof.

15. The method of claim 11 , wherein the lumbar nerve comprises an 1-1 nerve, 1-2 nerve, 1-3 nerve, 1-4 nerve, 1-5 nerve, or a combination thereof.

16. The method of claim 11 , wherein the sacral nerve comprises an s-1 nerve, s-2 nerve, s-3 nerve, s-4 nerve, s-5 nerve, or a combination thereof.

17. The method of claim 11 , wherein the administered botulinum toxin comprises botulinum toxin type A, botulinum toxin type B, botulinum toxin type C, botulinum toxin type D, botulinum toxin type E, botulinum toxin type F, botulinum toxin type G, a fragment thereof, a hybrid thereof, a chimera thereof, or a combination thereof.

18. The method of claim 11 , wherein each of the subcutaneous or intradermal injection is bilateral.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2020
From: WILLIAMS, ROLAND M.
To: PENLAND FOUNDATION
Reel/Frame 052694/0097 →
Continuity (2)
Continuation In Part 16657933 · Oct 18, 2019
Continuation In Part 16657950 · Oct 18, 2019
Cited By (4)
US 12,251,431 US 12,544,432 US 12,636,343 US 12,697,375