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Claims for Patent: 7,018,983

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Claims for Patent: 7,018,983

Title:Treatment of migraine
Abstract:A method for treating migraine in non-epileptic subjects which involves administering to subjects an effective amount of a pharmaceutical composition comprising a sulfamate of the following formula: ##STR00001##
Inventor(s): Ehrenberg; Bruce L. (Boston, MA), Wagner; Anita K. (Arlington, MA)
Assignee: New England Medical Center Hospitals, Inc. (Boston, MA)
Application Number:10/254,454
Patent Claims: 1. A method for migraine prophylaxis in a non-epileptic human patient diagnosed as having suffered at least one migraine headache, the method comprising administering to the patient (a) an effective amount of a sulfamate of the following formula (I): ##STR00006## wherein X is oxygen; R.sub.1 is hydrogen or a lower alkyl; and R.sub.2, R.sub.3, R.sub.4 and R.sub.5 are independently hydrogen or a lower alkyl, and R.sub.2 and R.sub.3 and/or R.sub.4 and R.sub.5 together are a methylenedioxy group of the following formula (II): ##STR00007## wherein R.sub.6 and R.sub.7 are the same or different and are hydrogen, lower alkyl or are alkyl and are joined to form a cyclopentyl or cyclohexyl ring; or (b) an effective amount of a derivative of a sulfamate of formula I, wherein the derivative is a pharmaceutically acceptable ester of a sulfamate of formula I or a salt of the ester.

2. The method of claim 1 wherein R.sub.2 and R.sub.3, and R.sub.4 and R.sub.5, together are groups of the formula (II).

3. The method of claim 1, wherein R.sub.1 is alkyl of about 1 to 4 carbons; said lower alkyl group for R.sub.2, R.sub.3, R.sub.4 and R.sub.5 is alkyl of about 1 to 3 carbons; and said lower alkyl for R.sub.6 and R.sub.7 is alkyl of about 1 to 3 carbons.

4. The method of claim 1, wherein said sulfamate of formula (I) is: (tetrahydro-2H-pyran-2-yl)methane sulfamate; 2,3:4,5-bis-O-(1-methylethyldiene)-.beta.-D-fructopyranose sulfamate; or 2,3:4,5-bis-O-(1-methylethyldiene)-.beta.-D-fructopyranose methylsulfamate.

5. The method of claim 4, wherein the sulfamate of formula (I) is 2,3:4,5-bis-O-(1-methylethyldiene)-.beta.-D-fructopyranose sulfamate.

6. The method of claim 4 wherein the sulfamate formula (I) is 2,3:4,5-bis-O-(1-methylethyldiene)-.beta.-D-fructopyranose methylsulfamate.

7. The method of claim 1, wherein the sulfamate of formula (I) is administered together with a pharmaceutically acceptable carrier.

8. The method of claim 1, wherein the sulfamate of formula (I) is present in a unit dosage amount of about 50 to 400 milligrams.

9. The method of claim 1, wherein the two oxygen atoms of the group of formula (II) are attached on the same side of the six-membered ring depicted in formula (I).

10. The method of claim 1, wherein the sulfamate of formula (I) is a fructopyranose.

11. The method of claim 1, wherein, in formula (I), R.sub.1 is hydrogen.

12. The method of claim 1, wherein the derivative is a pharmaceutically acceptable ester of formula I.

13. The method of claim 1, wherein the derivative is a pharmaceutically acceptable salt of an ester of formula I.

14. A method for migraine prophylaxis in a non-epileptic human patient diagnosed as having suffered at least one migraine headache, the method comprising administering to the patient an effective amount of a sulfamate of the following formula (I): ##STR00008## wherein X is oxygen; R.sub.1 is hydrogen or a lower alkyl; and R.sub.2, R.sub.3, R.sub.4 and R.sub.5 are independently hydrogen or a lower alkyl, and R.sub.2 and R.sub.3 and/or R.sub.4 and R.sub.5 together are a methylenedioxy group of the following formula (II): ##STR00009## wherein R.sub.6 and R.sub.7 are the same or different and are hydrogen, lower alkyl or are alkyl and are joined to form a cyclopentyl or cyclohexyl ring.

15. The method of claim 14, wherein the sulfamate of formula (I) is present in a unit dosage amount of about 50 to 400 milligrams.

16. The method of claim 14, wherein the sulfamate of formula (I) is present in a unit dosage amount of about 100 to 200 milligrams.

17. The method of claim 14, wherein the sulfamate of formula (I) is 2,3:4,5-bis-O-(1-methylethyldiene)-.beta.-D-fructopyranose sulfamate.

18. The method of claim 17, wherein the sulfamate of formula (I) is present in a unit dosage amount of about 50 to 400 milligrams.

19. The method of claim 18, wherein the sulfamate of formula (I) is present in a unit dosage amount of about 100 to 200 milligrams.

20. A method for migraine prophylaxis in a non-epileptic human patient diagnosed as having suffered at least one migraine headache, the method comprising administering to the patient an effective amount of a pharmaceutically acceptable derivative of a sulfamate of the following formula (I): ##STR00010## wherein X is oxygen; R.sub.1 is hydrogen or a lower alkyl; and R.sub.2, R.sub.3, R.sub.4 and R.sub.5 are independently hydrogen or a lower alkyl, and R.sub.2 and R.sub.3 and/or R.sub.4 and R.sub.5 together are a methylenedioxy group of the following formula (II): ##STR00011## wherein R.sub.6 and R.sub.7 are the same or different and are hydrogen, lower alkyl or are alkyl and are joined to form a cyclopentyl or cyclohexyl ring and wherein the derivative is a compound of formula (I) in which the sulfamate portion is masked by an imidate group or is a sorbopyranose sulfamate, a fructopyranose cyclic sulfite or sulfate, or a phenylethylsulfamate.

21. A method for migraine prophylaxis in a non-epileptic human patient diagnosed as having suffered at least one migraine headache, the method comprising administering to the patient a therapeutically effective amount of acetazolamide or methazolamide.
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