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Claims for Patent: 7,498,311

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Claims for Patent: 7,498,311

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. (Cambridge, MA)
Assignee: New England Medical Center Hospitals, Inc. (Boston, MA)
Application Number:11/326,783
Patent Claims: 1. A method of treating migraine in a human patient comprising administering to the patient a therapeutically effective amount of a compound of formula (I): ##STR00006## wherein X is oxygen; R.sub.1 is hydrogen or lower alkyl; and R.sub.2, R.sub.3, R.sub.4 and R.sub.5 are independently hydrogen or 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, and wherein the therapeutically effective amount is in the range of from about 0.5 mg/kg/day to about 15 mg/kg/day.

2. The method of claim 1, wherein the compound of formula (I) is topiramate.

3. The method of claim 2, wherein the therapeutically effective amount is in the range of from about 1 mg/kg/day to about 10 mg/kg/day.

4. The method of claim 3, wherein the therapeutically effective amount is in the range of from about 1 mg/kg/day to about 5 mg/kg/day.

5. The method of claim 2, wherein the topiramate is given one to two times daily.

6. The method of claim 2, wherein the topiramate is given in a single or divided doses.

7. The method of claim 2, wherein the topiramate is administered orally.

8. A method of reducing the frequency or severity of migrainous episodes in a human patient comprising administering to the patient a therapeutically effective amount of a compound of formula (I): ##STR00008## wherein X is oxygen; R.sub.1 is hydrogen or lower alkyl; and R.sub.2, R.sub.3, R.sub.4 and R.sub.5 are independently hydrogen or 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, and wherein the therapeutically effective amount is in the range of from about 0.5 mg/kg/day to about 15 mg/kg/day.

9. The method of claim 8, wherein the compound of formula (I) is topiramate.

10. The method of claim 9, wherein the therapeutically effective amount is in the range of from about 1 mg/kg/day to about 10 mg/kg/day.

11. The method of claim 9, wherein the therapeutically effective amount is in the range of from about 1 mg/kg/day to about 5 mg/kg/day.

12. The method of claim 9, wherein the topiramate is given one to two times daily.

13. The method of claim 9, wherein the topiramate is given in a single or divided doses.

14. The method of claim 9, wherein the topiramate is administered orally.

15. A method of migraine prophylaxis in a human patient diagnosed as having suffered at least one migraine headache, comprising administering to the patient a therapeutically effective amount of a compound of formula (I): ##STR00010## wherein X is oxygen; R.sub.1 is hydrogen or lower alkyl; and R.sub.2, R.sub.3, R.sub.4 and R.sub.5 are independently hydrogen or 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 therapeutically effective amount is in the range of from about 0.5 mg/kg/day to about 15 mg/kg/day.

16. The method of claim 15, wherein the compound of formula (I) is topiramate.

17. The method of claim 16, wherein the therapeutically effective amount is in the range of from about 1 mg/kg/day to about 10 mg/kg/day.

18. The method of claim 16, wherein the therapeutically effective amount is in the range of from about 1 mg/kg/day to about 5 mg/kg/day.

19. The method of claim 16, wherein the topiramate is given one to two times daily.

20. The method of claim 16, wherein the topiramate is given in a single or divided doses.

21. The method of claim 16, wherein the topiramate is administered orally.

22. A method of treating migraine comprising administering to a patient in need thereof, a daily dosage of topiramate or a daily dosage of a pharmaceutical composition comprising topiramate; wherein the daily dosage amount is in the range of from about 50 mg and about 800 mg.

23. The method of claim 22, wherein the daily dosage amount is in the range of from about 50 mg to about 400 mg.

24. A method of reducing the frequency or severity of migrainous episodes in a patient comprising administering to a patient in need thereof, a daily dosage of topiramate or a daily dosage of a pharmaceutical composition comprising topiramate; wherein the daily dosage amount is in the range of from about 50 mg and about 800 mg.

25. The method of claim 24, wherein the daily dosage is in the range of from about 50 mg to about 400 mg.
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