COMPOSITIONS AND METHODS FOR TREATMENT OF GULF WAR ILLNESS

• US 20140107140A1
• Filed: 12/19/2013
• Published: 04/17/2014
• Est. Priority Date: 06/24/2011
• Status: Abandoned Application

• Current Assignee: K-PAX Pharmaceuticals, Inc.
• Original Assignee: K-PAX Pharmaceuticals, Inc.
• Inventors: Kaiser, Jon D.
• Application Number:
  US14/134,605
• Publication Number:
  US 20140107140A1
• Time in Patent Office: Days
• US Class Current: 514/274
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/18 Sulfonamides compounds containing a para-N-benzene-sulfonyl-N- group A61K31/63
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 31/197 the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid carnitine A61K31/205
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/205 Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
• CPC Class Codes: A61K 31/381 having five-membered rings
• CPC Class Codes: A61K 31/385 having two or more sulfur atoms in the same ring
• CPC Class Codes: A61K 31/4415 Pyridoxine, i.e. Vitamin B6 pyridoxal phosphate A61K31/675
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 31/522 having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
• CPC Class Codes: A61K 31/714 Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

Pharmaceutical compositions and methods for the treatment of Gulf War Illness in human patients comprising administering a central nervous system (CNS) stimulant in a daily low-dosage amount, and micronutrients acetyl L-carnitine, L-tyrosine, N-acetyl cysteine, and alpha-lipoic acid. The CNS stimulant and micronutrient components may be in admixture for convenient daily oral administration of a low dosage CNS stimulant and micronutrients in the range of about 60-250 mg acetyl L-carnitine, 50-200 mg L-tyrosine, 60-250 mg N-acetyl cysteine, and 25-100 mg alpha-lipoic acid per day.

Claims

1. A method for treating Gulf War Illness in a human patient comprising:

administering a daily low-dosage amount of a central nervous system stimulant and therapeutically effective daily dosages of acetyl L-carnitine, L-tyrosine, N-acetyl cysteine, and alpha lipoic acid.

2. The method of claim 1, wherein acetyl L-carnitine is administered in a range of about 100 to 2000 mg.

3. The method of claim 1, wherein acetyl L-carnitine is administered in a range of about 400 to 1600 mg.

4. The method of claim 1, wherein L-tyrosine is administered in a range of about 100 to 2000 mg.

5. The method of claim 1, wherein L-tyrosine is administered in a range of 350 to 1400 mg.

6. The method of claim 1, wherein N-acetyl cysteine is administered in a range of 100 to 2000 mg.

7. The method of claim 1, wherein N-acetyl cysteine is administered in a range of 250 to 1250 mg.

8. The method of claim 1, wherein alpha-lipoic acid is administered in a range of 50 to 1000 mg.

9. The method of claim 1, wherein alpha-lipoic acid is administered in a range of 150 to 600 mg.

10. The method of claim 1, wherein said administering is conducted on a continuous basis for at least 12 weeks.

11. The method of claim 1, wherein the Gulf War Illness is associated with chronic fatigue syndrome.

12. The method of claim 1, wherein the Gulf War Illness is associated with fibromyalgia.

13. The method of claim 1, wherein the CNS stimulant and nutrients are orally administered together in a combined tablet.

14. The method of claim 1, wherein the CNS stimulant is methylphenidate.

15. The method of claim 14, wherein the methylphenidate is administered in an amount of 2.5 to 40 mg/day.

16. The method of claim 14, wherein the methylphenidate is administered in an amount less than 20 mg/day.

17. The method of claim 1, wherein the CNS stimulant is modafinil.

18. The method of claim 17, wherein the modafinil is administered in an amount of 30 to 100 mg/day.

19. The method of claim 17, wherein the modafinil is administered in an amount of 30 to 50 mg/day.

20. The method of claim 1, wherein the CNS stimulant is armodafinil.

21. The method of claim 20, wherein the armodafinil is administered in an amount of 20 to 80 mg/day.

22. The method of claim 20, wherein the armodafinil is administered in an amount of 20 to 40 mg/day.

23. The method of claim 1, wherein the CNS stimulant is dexmethylphenidate.

24. The method of claim 23, wherein the dexmethylphenidate is administered in an amount of 2.5 to 10 mg/day.

25. The method of claim 23, wherein the dexemthylphenidate is administered in an amount of 2.5 to 5 mg/day.

26. The method of claim 1, wherein the CNS stimulant is an amphetamine.

27. The method of claim 26, wherein the amphetamine is administered in an amount of 2.5 to 20 mg/day.

28. The method of claim 26, wherein the amphetamine is administered in an amount of 2.5 to 10 mg/day.

29. The method of claim 1, wherein the CNS stimulant is atomoxetine.

30. The method of claim 29, wherein the atomoxetine is administered in an amount of 20 to 50 mg/day.

31. The method of claim 29, wherein the atomexetine is administered in an amount of 20 to 25 mg/day.

32. The method of claim 1, wherein the CNS stimulant comprises caffeine.

33. The method of claim 32, wherein the caffeine is administered in an amount of 15 to 200 mg/day.

34. The method of claim 32, wherein the caffeine is administered in an amount of 30 to 125 mg/day.