Trial Outcomes & Findings for Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments. (NCT NCT04740827)
NCT ID: NCT04740827
Last Updated: 2023-09-21
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. The monthly (4-week) migraine days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis.
COMPLETED
PHASE3
315 participants
Baseline to Week 12
2023-09-21
Participant Flow
A total of 315 participants were randomized to receive atogepant-matching placebo or atogepant in a double-blind treatment period, and 313 participants received at least 1 dose of study intervention (safety population). From the 295 participants who completed the double-blind period 87 participants entered the follow-up period. Participants who rolled over directly at Week 12 to study 3101-312-002 \[NCT04686136\] did not enter the safety-follow up period.
Participant milestones
| Measure |
Placebo
Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.
|
Atogepant 60 mg
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Double-blind Treatment (Up to Week 12)
STARTED
|
158
|
157
|
|
Double-blind Treatment (Up to Week 12)
Safety Population
|
157
|
156
|
|
Double-blind Treatment (Up to Week 12)
Modified Intent-to-Treat (mITT) Population
|
154
|
151
|
|
Double-blind Treatment (Up to Week 12)
Off-treatment Hypothetical Estimand (OTHE) Population
|
155
|
154
|
|
Double-blind Treatment (Up to Week 12)
COMPLETED
|
151
|
144
|
|
Double-blind Treatment (Up to Week 12)
NOT COMPLETED
|
7
|
13
|
|
Follow-up Period (Week 13 to Week 16)
STARTED
|
43
|
44
|
|
Follow-up Period (Week 13 to Week 16)
COMPLETED
|
42
|
44
|
|
Follow-up Period (Week 13 to Week 16)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.
|
Atogepant 60 mg
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Double-blind Treatment (Up to Week 12)
Adverse Event
|
2
|
4
|
|
Double-blind Treatment (Up to Week 12)
Lack of Efficacy
|
0
|
1
|
|
Double-blind Treatment (Up to Week 12)
Withdrawal by Subject
|
2
|
2
|
|
Double-blind Treatment (Up to Week 12)
Pregnancy
|
0
|
1
|
|
Double-blind Treatment (Up to Week 12)
Protocol Deviation
|
3
|
5
|
|
Follow-up Period (Week 13 to Week 16)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
mITT population included all randomized participants who received at least 1 dose of study intervention.
Baseline characteristics by cohort
| Measure |
Placebo
n=158 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=157 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 10.29 • n=158 Participants
|
40.8 years
STANDARD_DEVIATION 10.71 • n=157 Participants
|
42.1 years
STANDARD_DEVIATION 10.56 • n=315 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=158 Participants
|
140 Participants
n=157 Participants
|
281 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=158 Participants
|
17 Participants
n=157 Participants
|
34 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=158 Participants
|
7 Participants
n=157 Participants
|
11 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=158 Participants
|
150 Participants
n=157 Participants
|
304 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
4 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
7 Participants
n=315 Participants
|
|
Race (NIH/OMB)
White
|
152 Participants
n=158 Participants
|
150 Participants
n=157 Participants
|
302 Participants
n=315 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Monthly Migraine Days in mITT Population
|
9.3 Migraine days per month
STANDARD_DEVIATION 2.41 • n=154 Participants • mITT population included all randomized participants who received at least 1 dose of study intervention.
|
9.0 Migraine days per month
STANDARD_DEVIATION 2.30 • n=151 Participants • mITT population included all randomized participants who received at least 1 dose of study intervention.
|
9.2 Migraine days per month
STANDARD_DEVIATION 2.35 • n=305 Participants • mITT population included all randomized participants who received at least 1 dose of study intervention.
|
|
Monthly Migraine Days in OTHE Population
|
9.3 Migraine days per month
STANDARD_DEVIATION 2.40 • n=155 Participants • OTHE population consisted of all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study intervention or off study intervention.
|
9.1 Migraine days per month
STANDARD_DEVIATION 2.29 • n=154 Participants • OTHE population consisted of all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study intervention or off study intervention.
|
9.2 Migraine days per month
STANDARD_DEVIATION 2.34 • n=309 Participants • OTHE population consisted of all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study intervention or off study intervention.
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period.
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis.
Outcome measures
| Measure |
Placebo
n=154 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=151 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
|
-1.86 migraine days per month
Standard Error 0.389
|
-4.29 migraine days per month
Standard Error 0.397
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment.
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
Outcome measures
| Measure |
Placebo
n=155 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=154 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population
|
-1.85 migraine days per month
Standard Error 0.388
|
-4.20 migraine days per month
Standard Error 0.393
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period.
Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to 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.
Outcome measures
| Measure |
Placebo
n=154 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=151 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population
|
27 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment.
Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to 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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=154 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population
|
28 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period.
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 pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were 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. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
Outcome measures
| Measure |
Placebo
n=154 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=151 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population
|
-1.93 headache days per month
Standard Error 0.424
|
-4.21 headache days per month
Standard Error 0.431
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment.
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 pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were 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. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
Outcome measures
| Measure |
Placebo
n=155 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=154 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population
|
-1.91 headache days per month
Standard Error 0.423
|
-4.10 headache days per month
Standard Error 0.429
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period.
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=154 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=151 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population
|
-1.11 acute medication use days per month
Standard Error 0.359
|
-3.79 acute medication use days per month
Standard Error 0.363
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment.
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=155 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=154 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population
|
-1.10 acute medication use days per month
Standard Error 0.358
|
-3.70 acute medication use days per month
Standard Error 0.361
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. Overall number of participants analyzed are the number of participants available for analysis.
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis.
Outcome measures
| Measure |
Placebo
n=149 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=144 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population
|
15.41 score on a scale
Standard Error 2.078
|
33.09 score on a scale
Standard Error 2.102
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment. Overall number of participants analyzed is the number of participants available for analysis.
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=144 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population
|
15.38 score on a scale
Standard Error 2.047
|
33.26 score on a scale
Standard Error 2.065
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. Overall number of participants analyzed is the number of participants available for analysis.
The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).
Outcome measures
| Measure |
Placebo
n=150 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=145 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) Across the 12-Week Treatment Period in mITT Population
|
-4.97 score on a scale
Standard Error 0.800
|
-9.68 score on a scale
Standard Error 0.826
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. Overall number of participants analyzed is the number of participants available for analysis.
The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).
Outcome measures
| Measure |
Placebo
n=150 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=145 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population
|
-3.03 score on a scale
Standard Error 0.748
|
-7.43 score on a scale
Standard Error 0.773
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment. Overall number of participants analyzed is the number of participants available for analysis.
HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=144 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population
|
-4.14 score on a scale
Standard Error 0.795
|
-10.56 score on a scale
Standard Error 0.804
|
SECONDARY outcome
Timeframe: From first dose of study drug until 30 days after last dose of study drug (up to Week 12)Population: Safety population consisted of all participants who received at least 1 dose of study intervention.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. TEAEs were defined as any AE with the onset that was after the first dose of study intervention.
Outcome measures
| Measure |
Placebo
n=157 Participants
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=156 Participants
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
|
84 Participants
|
81 Participants
|
Adverse Events
Placebo
Atogepant 60 mg
Serious adverse events
| Measure |
Placebo
n=157 participants at risk
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=156 participants at risk
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/157 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
0.64%
1/156 • Number of events 1 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER STAGE II
|
0.00%
0/157 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
0.64%
1/156 • Number of events 1 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE BREAST CARCINOMA
|
0.00%
0/157 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
0.64%
1/156 • Number of events 1 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/157 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
0.64%
1/156 • Number of events 1 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Placebo
n=157 participants at risk
Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.
|
Atogepant 60 mg
n=156 participants at risk
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
2.5%
4/157 • Number of events 4 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
10.3%
16/156 • Number of events 18 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
NAUSEA
|
3.2%
5/157 • Number of events 5 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
7.1%
11/156 • Number of events 12 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
9.6%
15/157 • Number of events 15 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
8.3%
13/156 • Number of events 13 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.6%
12/157 • Number of events 12 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
5.1%
8/156 • Number of events 10 • All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER