Claims for Patent: 12,383,545

Summary for Patent: 12,383,545

Title:	Treatment of migraine
Abstract:	The present disclosure provides methods for the treatment of migraine by the administration of atogepant or a pharmaceutically acceptable salt thereof.
Inventor(s):	Joel M. Trugman, Michelle Finnegan
Assignee:	Allergan Pharmaceuticals International Ltd
Application Number:	US19/092,662
Patent Claims:	1. A method for the preventive treatment of migraine in a patient in need thereof, the method comprising orally administering atogepant to the patient in a therapeutically effective amount of 10 mg once daily, wherein the method does not significantly affect the level of liver enzymes in the patient. 2. The method of claim 1, wherein alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in the patient are less than 3 times the upper limit of normal for the duration of treatment. 3. The method of claim 1, wherein when the method is used for a duration of 12 weeks to treat a population of patients with 4 to 14 migraine days per month prior to initiation of the method, the method results in a reduction in mean monthly migraine days of at least about 3.7 days in the population at 12 weeks from initiation of the method. 4. The method of claim 1, wherein the patient has 4 to 14 migraine days per month prior to the administration of atogepant. 5. The method of claim 4, wherein alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in the patient are less than 3 times the upper limit of normal for the duration of treatment. 6. The method of claim 4, wherein when the method is used for a duration of 12 weeks to treat a population of patients with 4 to 14 migraine days per month prior to initiation of the method, the method results in a reduction in mean monthly migraine days of at least about 3.7 days in the population at 12 weeks from initiation of the method. 7. A method for the preventive treatment of migraine in a patient in need thereof, the method comprising orally administering atogepant to the patient in a therapeutically effective amount of 30 mg once daily, wherein the method does not significantly affect the level of liver enzymes in the patient. 8. The method of claim 7, wherein alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in the patient are less than 3 times the upper limit of normal for the duration of treatment. 9. The method of claim 7, wherein when the method is used for a duration of 12 weeks to treat a population of patients with 4 to 14 migraine days per month prior to initiation of the method, the method results in a reduction in mean monthly migraine days of at least about 3.9 days in the population at 12 weeks from initiation of the method. 10. The method of claim 7, wherein the patient has 4 to 14 migraine days per month prior to the administration of atogepant. 11. The method of claim 10, wherein alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in the patient are less than 3 times the upper limit of normal for the duration of treatment. 12. The method of claim 10, wherein when the method is used for a duration of 12 weeks to treat a population of patients with 4 to 14 migraine days per month prior to initiation of the method, the method results in a reduction in mean monthly migraine days of at least about 3.9 days in the population at 12 weeks from initiation of the method. 13. A method for the preventive treatment of migraine in a patient in need thereof, the method comprising orally administering atogepant to the patient in a therapeutically effective amount of 60 mg once daily, wherein the method does not significantly affect the level of liver enzymes in the patient. 14. The method of claim 13, wherein alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in the patient are less than 3 times the upper limit of normal for the duration of treatment. 15. The method of claim 13, wherein when the method is used for a duration of 12 weeks to treat a population of patients with 4 to 14 migraine days per month prior to initiation of the method, the method results in a reduction in mean monthly migraine days of at least about 4.2 days in the population at 12 weeks from initiation of the method. 16. The method of claim 13, wherein the patient has 4 to 14 migraine days per month prior to the administration of atogepant. 17. The method of claim 16, wherein alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in the patient are less than 3 times the upper limit of normal for the duration of treatment. 18. The method of claim 16, wherein when the method is used for a duration of 12 weeks to treat a population of patients with 4 to 14 migraine days per month prior to initiation of the method, the method results in a reduction in mean monthly migraine days of at least about 4.2 days in the population at 12 weeks from initiation of the method.