TREATMENT OF MIGRAINE
The present disclosure provides methods for the treatment of migraine by the administration of atogepant or a pharmaceutically acceptable salt thereof.
1 . A method of prophylactically treating migraine, the method comprising administering atogepant or a pharmaceutically acceptable salt thereof in an amount of 10 mg QD, 30 mg QD, or 60 mg QD.
2 . The method of claim 1 , wherein the prophylactic treatment results in a reduction in mean monthly migraine days of at least 3.6 days.
3 . The method of claim 2 , wherein the prophylactic treatment results in a reduction in mean monthly migraine days of at least 3.8 days.
4 . The method of claim 3 , wherein the prophylactic treatment results in a reduction in mean monthly migraine days of at least 4.2 days.
5 . The method of claim 1 , wherein the prophylactic treatment results in at least 50% reduction in monthly migraine days.
6 . The method of claim 1 , wherein the prophylactic treatment results in a reduction in mean monthly headache days of at least 3.9 days.
7 . The method of claim 1 , wherein the prophylactic treatment results in a reduction in mean monthly headache days of at least 4 days.
8 . The method of claim 1 , wherein the prophylactic treatment results in a reduction in mean monthly headache days of at least 4.2 days.
9 . A method of preventing migraine in a patient having fewer than fifteen migraine days per month, the method comprising administering atogepant in an amount of 10 mg QD, 30 mg QD, or 60 mg QD, wherein administering atogepant results in a reduction in mean monthly migraine days of at least about 3.6 days.
10 . The method according to claim 9 , wherein administering atogepant results in a reduction in mean monthly migraine days of at least about 3.8 days.
11 . The method according to claim 9 , wherein administering atogepant results in a reduction in mean monthly migraine days of at least 4.2 days.
12 . The method according to claim 9 , wherein administering atogepant results in a reduction in mean monthly headache days of at least about 4.2 days.
13 . A method of preventing migraine, the method comprising administering atogepant in an amount of about 10 mg QD, about 30 mg QD, or about 60 mg QD, wherein administration of atogepant results in an improvement in ability to perform daily activities as compared to a pre-treatment baseline or a patient not receiving atogepant.
14 . The method according to claim 13 , wherein the improvement in ability to perform daily activities is assessed by the MSQ v2.1.
15 . The method according to claim 14 , wherein administration of atogepant results in a change from baseline in the MSQ v2.1 RFR domain of greater than about 25 points.
16 . The method according to claim 15 , wherein atogepant is administered in an amount of about 10 mg QD, and wherein administration of atogepant results in a change in the MSQ v2.1 RFR domain of about 30.4 points from baseline.
17 . The method according to claim 15 , wherein atogepant is administered in an amount of about 30 mg QD, and wherein administration of atogepant results in a change in the MSQ v2.1 RFR domain of about 30.5 points relative to baseline.
18 . The method according to claim 15 , wherein atogepant is administered in an amount of about 60 mg QD, and wherein administration of atogepant results in a change in the MSQ v2.1 RFR domain of about 31.3 points relative to baseline.
19 . The method of claim 9 , wherein atogepant is administered for at least about 4 weeks, and wherein administration of atogepant results in a reduction in body weight from baseline of at least about 0.5 kg.
20 . The method of claim 19 , wherein atogepant is administered daily for at least about nine months.
21 . The method of claim 19 , wherein atogepant is administered daily for at least about 12 months.
22 . The method of claim 21 , wherein administration of atogepant results in a reduction in body weight from baseline of at least about 1.42 kg.
23 . The method of claim 21 , wherein at least about 22% of patients achieve a weight decrease of greater than about 5% relative to baseline.
24 . A method for the preventive treatment of migraine in patients having fewer than fifteen migraine days per month, the method comprising administering atogepant in an amount of 30 mg QD or 60 mg QD for at least about 12 weeks, wherein administration of atogepant results in a reduction in body weight of at least about 0.4 kg.
25 . The method of claim 24 , wherein atogepant is administered in an amount of 30 mg QD.
26 . The method of claim 25 , wherein atogepant is administered daily for at least about 52 weeks.
27 . The method of claim 25 , wherein at least about 3.2% of patients achieve a weight loss of greater than 7% relative to baseline body weight.
28 . The method of claim 24 , wherein atogepant is administered in an amount of 60 mg QD.
29 . The method of claim 28 , wherein administration of atogepant results in a reduction in body weight of at least about 0.8 kg.
30 . The method of claim 28 , wherein at least about 4.9% of patients achieve a weight loss of greater than 7% relative to baseline body weight.