IP Library › Granted Patent US 11,744,881
Granted Patent B2
US 11,744,881 · App. 17/215,082 · Granted Sep 5, 2023

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 11,744,881
App. No.
17/215,082
Granted
Sep 5, 2023
Kind
B2
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 (22)

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 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 patient's spine, 1-4 units to and/or around the vicinity of a lumbar nerve, lateral to the patient's spine, and/or 1-4 units to and/or around the vicinity of a sacral nerve, lateral to the patient's spine, and

monitoring if the patient's neuroexcitatory substances levels normalize.

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 1-2 nerve, t-3 nerve, t-5 nerve, t-6 nerve, t-7 nerve, t-8 nerve, 1-9 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 a total dosage of the botulinum toxin for an adult who weighs about 150 lbs. is between about 1 unit and about 150 units.

9. The method of claim 8 , wherein a total dosage of the botulinum toxin for an adult, a child is adjusted for age, weight, or a combination thereof.

10. The method of claim 1 , wherein the neuroexcitatory substances are substance P, calcitonin gene-related peptide (CGRP) or glutamate.

11. The method of claim 1 , wherein the patient's neuroexcitatory substances level are blood levels.

12. The method of claim 1 , wherein the monitoring if the patient's neuroexcitatory substances levels normalize comprises monitoring if the patient's blood glutamate level normalizes.

13. The method of claim 12 , wherein a normal blood glutamate level is from about 40 to about 60 uM.

14. The method of claim 1 , wherein if the patient's neuroexcitatory substances levels fail to normalize, additional botulinum toxin is administered to the patient.

15. The method of claim 14 , wherein if the patient's neuroexcitatory substances levels fail to normalize even after administering the additional botulinum toxin, an antagonist to the neuroexcitatory substances is administered to the patient.

16. The method of claim 1 , wherein if the patient's neuroexcitatory substances levels fail to normalize, an antagonist to the neuroexcitatory substances is administered to the patient.

17. The method of claim 1 , wherein the monitoring if the patient's neuroexcitatory substances levels normalize occurs or two weeks after the administering botulinum toxin to the patient.

18. The method of claim 1 , further comprising monitoring the patient's physical symptoms.

19. The method of claim 18 , wherein if the patient's physical symptom continues, additional botulinum toxin or an antagonist to the neuroexcitatory substances is administered to the patient.

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

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 11, 2023
From: WILLIAMS, ROLAND M.
To: PENLAND FOUNDATION
Reel/Frame 064212/0601 →
Continuity (23)
Continuation 17204922 · Mar 17, 2021
Continuation 16995042 · Aug 17, 2020
Continuation 16875951 · May 15, 2020
Continuation 16875947 · May 15, 2020
Continuation 16875924 · May 15, 2020
Continuation 16875912 · May 15, 2020
Continuation 17215082
Continuation 16875945 · May 15, 2020
Continuation 16875935 · May 15, 2020
Continuation In Part 16657933 · Oct 18, 2019
Continuation In Part 16657933 · Oct 18, 2019
Continuation In Part 16657950 · Oct 18, 2019
Continuation In Part 16657933 · Oct 18, 2019
Continuation In Part 16657950 · Oct 18, 2019
Continuation In Part 16657950 · Oct 18, 2019
Continuation In Part 16657950 · Oct 18, 2019
Continuation In Part 16657950 · Oct 18, 2019
Continuation In Part 16657933 · Oct 18, 2019
Continuation 16657950 · Oct 18, 2019
Continuation In Part 16675933 · Oct 18, 2019
Continuation In Part 16657950 · Oct 18, 2019
Continuation In Part 16657933 · Oct 18, 2019
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