Compositions and methods of using (R)-pramipexole
Pharmaceutical compositions of (R)-pramipexole and methods and kits of using such compositions for the treatment of neurodegenerative diseases, or those related to mitochondrial dysfunction or increased oxidative stress are disclosed.
1. A method of treating amyotrophic lateral sclerosis in a patient in need thereof comprising administering to said patient a single unit dose of about 150 milligrams to about 5,000 milligrams of (R)-pramipexole in a pharmaceutical composition.
2. The method of claim 1 , wherein said patient is a naïve patient.
3. The method of claim 1 , wherein said single unit dose is from about 200 milligrams to about 3,000 milligrams of (R)-pramipexole.
4. The method of claim 1 , wherein said single unit dose is from about 300 milligrams to about 1,500 milligrams of (R)-pramipexole.
5. The method of claim 1 , wherein said single unit dose is from about 500 milligrams to about 1,000 milligrams of (R)-pramipexole.
6. The method of claim 1 , wherein the chiral purity for the (R)-pramipexole is 99.9%, or greater.
7. The method of claim 1 , wherein the chiral purity for the (R)-pramipexole is 99.95%, or greater.
8. The method of claim 1 , wherein the chiral purity for the (R)-pramipexole is 99.99% or greater.
9. The method of claim 1 , wherein said single unit dose is from about 200 mg to about 1,000 mg of (R)-pramipexole.
10. The method of claim 1 , wherein said single unit dose is from about 250 mg to about 1,000 mg of (R)-pramipexole.
11. The method of claim 1 , wherein said single unit dose is from about 300 mg to about 1,000 mg of (R)-pramipexole.
12. The method of claim 1 , wherein said single unit dose is from about 400 mg to about 1,000 mg of (R)-pramipexole.
13. The method of claim 1 , wherein said single unit dose is from about 600 mg to about 1,000 mg of (R)-pramipexole.
14. The method of claim 1 , wherein said single unit dose is from about 450 mg to about 1,000 mg of (R)-pramipexole.
15. The method of claim 1 , wherein said single unit dose is from about 600 mg to about 900 mg of (R)-pramipexole.
16. The method of claim 1 , wherein said single unit dose is about 150 milligrams.
17. The method of claim 1 , wherein said single unit dose is about 300 milligrams.
18. The method of claim 1 , wherein said pharmaceutical composition is administered in a route of administration selected from oral, ophthalmic, intravenous, intramuscular, intra-arterial, intramedular, intrathecal, intraventricular, transdermal, subcutaneous, intraperitoneal, intravesicular, intranasal, enteral, topical, sublingual and rectal.
19. The method of claim 1 , wherein said pharmaceutical composition is administered orally.
20. The method of claim 1 , wherein said pharmaceutical composition is selected from a tablet and a capsule.
21. The method of claim 1 , wherein said pharmaceutical composition comprises less than about 1.5 dopaminergic activity equivalents.
22. The method of claim 1 , wherein said pharmaceutical composition comprises less than about 0.5 dopaminergic activity equivalents.
23. The method of claim 1 , wherein said pharmaceutical composition comprises less than about 0.05 dopaminergic activity equivalents.
24. A method of treating amyotrophic lateral sclerosis in a naïve patient comprising administering to said naive patient a starting dose of about 300 milligrams of (R)-pramipexole or a pharmaceutical salt thereof in a single unit dose, wherein the chiral purity for the (R)-pramipexole is 99.95%.
25. A method of treating a amyotrophic lateral sclerosis in a naïve patient comprising administering to said naïve patient a starting dose of about 600 milligrams of (R)-pramipexole or a pharmaceutical salt thereof in a single unit dose, wherein the chiral purity for the (R)-pramipexole is 99.95%.
26. A method of treating amyotrophic lateral sclerosis in a patient comprising administering to said patient a pharmaceutical composition comprising about 150 milligrams of (R)-pramipexole or a pharmaceutical salt thereof in a single unit dose twice a day, wherein the chiral purity for the (R)-pramipexole is 99.95%.
27. A method of treating amyotrophic lateral sclerosis in a patient comprising administering to said patient a pharmaceutical composition comprising about 300 milligrams of (R)-pramipexole or a pharmaceutical salt thereof in a single unit dose twice a day, wherein the chiral purity for the (R)-pramipexole is 99.95%.
28. A method of treating amyotrophic lateral sclerosis of claim 24 , wherein said (R)-pramipexole or pharmaceutically acceptable salt thereof is (R)-pramipexole dihydrochloride monohydrate.
29. A method of treating amyotrophic lateral sclerosis of claim 25 , wherein said (R)-pramipexole or pharmaceutically acceptable salt thereof is (R)-pramipexole dihydrochloride monohydrate.
30. A method of treating amyotrophic lateral sclerosis of claim 26 , wherein said (R)-pramipexole or pharmaceutically acceptable salt thereof is (R)-pramipexole dihydrochloride monohydrate.
31. A method of treating amyotrophic lateral sclerosis of claim 27 , wherein said (R)-pramipexole is (R)-pramipexole dihydrochloride monohydrate.