Trial Outcomes & Findings for Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention (NCT NCT02848326)
NCT ID: NCT02848326
Last Updated: 2018-12-06
Results Overview
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4- week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
834 participants
Primary outcome timeframe
Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Results posted on
2018-12-06
Participant Flow
Participants diagnosed with migraine, with or without aura were enrolled in one of 6 treatment arms: placebo, or atogepant 10 mg once daily (QD), 30 mg QD, 60 mg QD, 30 mg twice daily (BID), or 60 mg BID.
Participant milestones
| Measure |
Placebo
Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
|
Atogepant 10 mg QD
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 30 mg QD
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 60 mg QD
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
|
Atogepant 30 mg BID
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
Atogepant 60 mg BID
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
186
|
94
|
185
|
187
|
89
|
93
|
|
Treatment Period
Safety Population: Received Study Drug
|
186
|
93
|
183
|
186
|
86
|
91
|
|
Treatment Period
COMPLETED
|
148
|
80
|
149
|
164
|
70
|
73
|
|
Treatment Period
NOT COMPLETED
|
38
|
14
|
36
|
23
|
19
|
20
|
|
Safety Follow-up Period
STARTED
|
161
|
84
|
156
|
169
|
77
|
82
|
|
Safety Follow-up Period
COMPLETED
|
157
|
83
|
153
|
169
|
76
|
77
|
|
Safety Follow-up Period
NOT COMPLETED
|
4
|
1
|
3
|
0
|
1
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
|
Atogepant 10 mg QD
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 30 mg QD
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 60 mg QD
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
|
Atogepant 30 mg BID
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
Atogepant 60 mg BID
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Treatment Period
Adverse Event
|
5
|
4
|
11
|
6
|
5
|
7
|
|
Treatment Period
Withdrawal of Consent
|
20
|
6
|
9
|
6
|
9
|
6
|
|
Treatment Period
Lost to Follow-up
|
5
|
1
|
11
|
7
|
2
|
3
|
|
Treatment Period
Pregnancy
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Treatment Period
Protocol Violation
|
4
|
3
|
4
|
2
|
3
|
3
|
|
Treatment Period
Non-compliance with Study Drug
|
4
|
0
|
0
|
1
|
0
|
0
|
|
Safety Follow-up Period
Withdrawal of Consent
|
0
|
1
|
1
|
0
|
0
|
2
|
|
Safety Follow-up Period
Lost to Follow-up
|
4
|
0
|
2
|
0
|
1
|
3
|
Baseline Characteristics
Modified-intent-to-treatment (mITT) Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
Baseline characteristics by cohort
| Measure |
Placebo
n=186 Participants
Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
|
Atogepant 10 mg QD
n=93 Participants
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 30 mg QD
n=183 Participants
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 60 mg QD
n=186 Participants
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
|
Atogepant 30 mg BID
n=86 Participants
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
Atogepant 60 mg BID
n=91 Participants
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
Total
n=825 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 11.7 • n=186 Participants
|
39.4 years
STANDARD_DEVIATION 12.4 • n=93 Participants
|
41.0 years
STANDARD_DEVIATION 13.6 • n=183 Participants
|
40.4 years
STANDARD_DEVIATION 11.7 • n=186 Participants
|
38.5 years
STANDARD_DEVIATION 11.2 • n=86 Participants
|
39.7 years
STANDARD_DEVIATION 11.9 • n=91 Participants
|
40.1 years
STANDARD_DEVIATION 12.2 • n=825 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=186 Participants
|
82 Participants
n=93 Participants
|
166 Participants
n=183 Participants
|
156 Participants
n=186 Participants
|
73 Participants
n=86 Participants
|
83 Participants
n=91 Participants
|
714 Participants
n=825 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=186 Participants
|
11 Participants
n=93 Participants
|
17 Participants
n=183 Participants
|
30 Participants
n=186 Participants
|
13 Participants
n=86 Participants
|
8 Participants
n=91 Participants
|
111 Participants
n=825 Participants
|
|
Race/Ethnicity, Customized
White
|
137 Participants
n=186 Participants
|
69 Participants
n=93 Participants
|
145 Participants
n=183 Participants
|
133 Participants
n=186 Participants
|
73 Participants
n=86 Participants
|
71 Participants
n=91 Participants
|
628 Participants
n=825 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
45 Participants
n=186 Participants
|
20 Participants
n=93 Participants
|
29 Participants
n=183 Participants
|
44 Participants
n=186 Participants
|
11 Participants
n=86 Participants
|
19 Participants
n=91 Participants
|
168 Participants
n=825 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=186 Participants
|
1 Participants
n=93 Participants
|
2 Participants
n=183 Participants
|
3 Participants
n=186 Participants
|
1 Participants
n=86 Participants
|
0 Participants
n=91 Participants
|
8 Participants
n=825 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=186 Participants
|
0 Participants
n=93 Participants
|
1 Participants
n=183 Participants
|
2 Participants
n=186 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=91 Participants
|
6 Participants
n=825 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 Participants
n=186 Participants
|
0 Participants
n=93 Participants
|
2 Participants
n=183 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=91 Participants
|
2 Participants
n=825 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
0 Participants
n=186 Participants
|
3 Participants
n=93 Participants
|
4 Participants
n=183 Participants
|
4 Participants
n=186 Participants
|
1 Participants
n=86 Participants
|
1 Participants
n=91 Participants
|
13 Participants
n=825 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
29 Participants
n=186 Participants
|
15 Participants
n=93 Participants
|
32 Participants
n=183 Participants
|
25 Participants
n=186 Participants
|
13 Participants
n=86 Participants
|
13 Participants
n=91 Participants
|
127 Participants
n=825 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
157 Participants
n=186 Participants
|
78 Participants
n=93 Participants
|
151 Participants
n=183 Participants
|
161 Participants
n=186 Participants
|
73 Participants
n=86 Participants
|
78 Participants
n=91 Participants
|
698 Participants
n=825 Participants
|
|
Migraine Days (Migraine/Probable Migraine Headache Days)
|
7.81 migraine days per month
STANDARD_DEVIATION 2.51 • n=178 Participants • Modified-intent-to-treatment (mITT) Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
|
7.63 migraine days per month
STANDARD_DEVIATION 2.51 • n=92 Participants • Modified-intent-to-treatment (mITT) Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
|
7.64 migraine days per month
STANDARD_DEVIATION 2.37 • n=182 Participants • Modified-intent-to-treatment (mITT) Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
|
7.74 migraine days per month
STANDARD_DEVIATION 2.59 • n=177 Participants • Modified-intent-to-treatment (mITT) Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
|
7.38 migraine days per month
STANDARD_DEVIATION 2.43 • n=79 Participants • Modified-intent-to-treatment (mITT) Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
|
7.62 migraine days per month
STANDARD_DEVIATION 2.56 • n=87 Participants • Modified-intent-to-treatment (mITT) Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
|
7.67 migraine days per month
STANDARD_DEVIATION 2.49 • n=795 Participants • Modified-intent-to-treatment (mITT) Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
|
PRIMARY outcome
Timeframe: Baseline (First 28 Days of Screening/Baseline Period) to Week 12Population: MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4- week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=178 Participants
Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
|
Atogepant 10 mg QD
n=92 Participants
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 30 mg QD
n=182 Participants
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 60 mg QD
n=177 Participants
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
|
Atogepant 30 mg BID
n=79 Participants
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
Atogepant 60 mg BID
n=87 Participants
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period
|
-2.85 migraine days per month
Standard Error 0.23
|
-4.00 migraine days per month
Standard Error 0.32
|
-3.76 migraine days per month
Standard Error 0.23
|
-3.55 migraine days per month
Standard Error 0.23
|
-4.23 migraine days per month
Standard Error 0.35
|
-4.14 migraine days per month
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline (First 28 Days of Screening/Baseline Period) to Week 12Population: MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration and acute symptomatic medication use. The 4-week (monthly) headache days was defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=178 Participants
Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
|
Atogepant 10 mg QD
n=92 Participants
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 30 mg QD
n=182 Participants
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 60 mg QD
n=177 Participants
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
|
Atogepant 30 mg BID
n=79 Participants
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
Atogepant 60 mg BID
n=87 Participants
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period
|
-2.93 headache days per month
Standard Error 0.25
|
-4.31 headache days per month
Standard Error 0.35
|
-4.17 headache days per month
Standard Error 0.25
|
-3.86 headache days per month
Standard Error 0.25
|
-4.23 headache days per month
Standard Error 0.38
|
-4.32 headache days per month
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Baseline (First 28 Days of Screening/Baseline Period) to Week 12Population: MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days=total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.
Outcome measures
| Measure |
Placebo
n=178 Participants
Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
|
Atogepant 10 mg QD
n=92 Participants
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 30 mg QD
n=182 Participants
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 60 mg QD
n=177 Participants
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
|
Atogepant 30 mg BID
n=79 Participants
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
Atogepant 60 mg BID
n=87 Participants
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period
|
40.4 percentage of participants
|
57.6 percentage of participants
|
53.3 percentage of participants
|
52.0 percentage of participants
|
58.2 percentage of participants
|
62.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (First 28 Days of Screening/Baseline Period) to Week 12Population: MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.
Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The 4-week (monthly) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=178 Participants
Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
|
Atogepant 10 mg QD
n=92 Participants
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 30 mg QD
n=182 Participants
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 60 mg QD
n=177 Participants
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
|
Atogepant 30 mg BID
n=79 Participants
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
Atogepant 60 mg BID
n=87 Participants
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period
|
-2.42 acute medication use days per month
Standard Error 0.21
|
-3.71 acute medication use days per month
Standard Error 0.29
|
-3.86 acute medication use days per month
Standard Error 0.20
|
-3.53 acute medication use days per month
Standard Error 0.21
|
-3.77 acute medication use days per month
Standard Error 0.31
|
-3.64 acute medication use days per month
Standard Error 0.29
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Atogepant 10 mg QD
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Atogepant 30 mg QD
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
Atogepant 60 mg QD
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Atogepant 30 mg BID
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Atogepant 60 mg BID
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=186 participants at risk
Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
|
Atogepant 10 mg QD
n=93 participants at risk
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 30 mg QD
n=183 participants at risk
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 60 mg QD
n=186 participants at risk
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
|
Atogepant 30 mg BID
n=86 participants at risk
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
Atogepant 60 mg BID
n=91 participants at risk
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.1%
1/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.54%
1/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Psychiatric disorders
Overdose
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.54%
1/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.54%
1/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.54%
1/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Ureteritis
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.55%
1/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.54%
1/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Migraine
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.55%
1/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
Other adverse events
| Measure |
Placebo
n=186 participants at risk
Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
|
Atogepant 10 mg QD
n=93 participants at risk
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 30 mg QD
n=183 participants at risk
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
|
Atogepant 60 mg QD
n=186 participants at risk
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
|
Atogepant 30 mg BID
n=86 participants at risk
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
Atogepant 60 mg BID
n=91 participants at risk
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
3.2%
6/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.1%
1/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.6%
3/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
2.7%
5/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
2.3%
2/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
9.9%
9/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
9/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
5.4%
5/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
7.1%
13/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
11.3%
21/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
8.1%
7/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
9.9%
9/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
4/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
2.2%
2/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
5.5%
10/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.8%
9/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.5%
3/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
6.6%
6/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
14/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
6.5%
6/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
7.1%
13/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.8%
9/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.7%
4/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
6.6%
6/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
4/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.2%
3/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
5.5%
10/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
7.5%
14/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.2%
1/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.1%
1/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.1%
2/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.2%
3/93 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.6%
3/183 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.1%
2/186 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
5.8%
5/86 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
2.2%
2/91 • Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER