12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03777059 |
|
Recruitment Status :
Completed
First Posted : December 17, 2018
Results First Posted : July 9, 2021
Last Update Posted : July 9, 2021
|
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
| Condition |
Episodic Migraine |
| Interventions |
Drug: Atogepant Drug: Placebo |
| Enrollment | 910 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Participants diagnosed with episodic migraine were enrolled in one of 4 treatment arms: placebo, or atogepant 10 mg once daily (QD), 30 mg QD, 60 mg QD in Double-blind (DB) Treatment Period. |
| Arm/Group Title | Placebo | Atogepant 10 mg | Atogepant 30 mg | Atogepant 60 mg |
|---|---|---|---|---|
 Arm/Group Description |
Placebo-matching atogepant tablets orally once daily for 12 weeks. | Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. | Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. | Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. |
| Period Title: DB Treatment Period (Up to Week 12) | ||||
| Started | 223 | 222 | 230 | 235 |
| Treated: Safety Population [1] | 222 | 221 | 228 | 231 |
| Completed [2] | 201 | 193 | 207 | 204 |
| Not Completed | 22 | 29 | 23 | 31 |
| Reason Not Completed | ||||
| Adverse Event | 6 | 9 | 4 | 6 |
| Lack of Efficacy | 1 | 0 | 0 | 1 |
| Withdrawal by Subject | 8 | 9 | 8 | 10 |
| Lost to Follow-up | 3 | 3 | 4 | 5 |
| Pregnancy | 0 | 1 | 0 | 0 |
| Protocol Deviation | 4 | 5 | 7 | 8 |
| Reason Not Specified | 0 | 2 | 0 | 1 |
|
[1]
Safety Population included all participants who received at least 1 dose of study intervention.
[2]
Out of 805 participants who completed DB Treatment Period, 683 participants did not complete follow-up since they rolled into study 3101-309-002 (NCT03939312), 183 entered Follow-Up Period.
|
||||
| Period Title: Follow-Up Period (Weeks 12 to 16) | ||||
| Started | 46 | 54 | 38 | 45 |
| Completed | 41 | 49 | 32 | 36 |
| Not Completed | 5 | 5 | 6 | 9 |
| Reason Not Completed | ||||
| Withdrawal by Subject | 5 | 3 | 4 | 5 |
| Lost to Follow-up | 0 | 1 | 0 | 3 |
| Protocol Deviation | 0 | 1 | 1 | 0 |
| Reason Not Specified | 0 | 0 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Placebo | Atogepant 10 mg | Atogepant 30 mg | Atogepant 60 mg | Total | |
|---|---|---|---|---|---|---|
|
Arm/Group Description |
Placebo-matching atogepant tablets orally once daily for 12 weeks. | Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. | Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. | Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 222 | 221 | 228 | 231 | 902 | |
|
Baseline Analysis Population Description |
Safety Population included all participants who received at least 1 dose of study intervention.
|
|||||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||||
| Number Analyzed | 222 participants | 221 participants | 228 participants | 231 participants | 902 participants | |
| 40.3 (12.81) | 41.4 (12.05) | 42.1 (11.68) | 42.5 (12.41) | 41.6 (12.25) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||
| Number Analyzed | 222 participants | 221 participants | 228 participants | 231 participants | 902 participants | |
| Female |
198 89.2%
|
200 90.5%
|
204 89.5%
|
199 86.1%
|
801 88.8%
|
|
| Male |
24 10.8%
|
21 9.5%
|
24 10.5%
|
32 13.9%
|
101 11.2%
|
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||
| Number Analyzed | 222 participants | 221 participants | 228 participants | 231 participants | 902 participants | |
| American Indian or Alaska Native |
0 0.0%
|
1 0.5%
|
1 0.4%
|
1 0.4%
|
3 0.3%
|
|
| Asian |
2 0.9%
|
2 0.9%
|
1 0.4%
|
7 3.0%
|
12 1.3%
|
|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Black or African American |
24 10.8%
|
34 15.4%
|
38 16.7%
|
28 12.1%
|
124 13.7%
|
|
| White |
194 87.4%
|
181 81.9%
|
185 81.1%
|
192 83.1%
|
752 83.4%
|
|
| More than one race |
2 0.9%
|
3 1.4%
|
3 1.3%
|
2 0.9%
|
10 1.1%
|
|
| Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 0.4%
|
1 0.1%
|
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
||||||
| Number Analyzed | 222 participants | 221 participants | 228 participants | 231 participants | 902 participants | |
| Hispanic |
23 10.4%
|
21 9.5%
|
19 8.3%
|
14 6.1%
|
77 8.5%
|
|
| Non-Hispanic |
199 89.6%
|
200 90.5%
|
209 91.7%
|
217 93.9%
|
825 91.5%
|
|
|
Monthly Migraine Days
[1] [2] Mean (Standard Deviation) Unit of measure: Migraine days per month |
||||||
| Number Analyzed | 214 participants | 214 participants | 223 participants | 222 participants | 873 participants | |
| 7.5 (2.39) | 7.5 (2.46) | 7.9 (2.32) | 7.8 (2.31) | 7.6 (2.37) | ||
|
[1]
Measure Description: A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (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.
[2]
Measure Analysis Population Description: mITT Population included 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 post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.
|
||||||
|
Monthly Headache Days
[1] [2] Mean (Standard Deviation) Unit of measure: Headache days per month |
||||||
| Number Analyzed | 214 participants | 214 participants | 223 participants | 222 participants | 873 participants | |
| 8.4 (2.55) | 8.4 (2.75) | 8.8 (2.62) | 9.0 (2.56) | 8.7 (2.63) | ||
|
[1]
Measure Description: A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. 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.
[2]
Measure Analysis Population Description: mITT Population included 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 post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.
|
||||||
|
Monthly Acute Medication Use
[1] [2] Mean (Standard Deviation) Unit of measure: Acute medication use days per month |
||||||
| Number Analyzed | 214 participants | 214 participants | 223 participants | 222 participants | 873 participants | |
| 6.5 (3.15) | 6.6 (2.99) | 6.7 (3.02) | 6.9 (3.17) | 6.7 (3.08) | ||
|
[1]
Measure Description: The monthly (4-week) 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.
[2]
Measure Analysis Population Description: mITT Population included 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 post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.
|
||||||
|
MSQ v2.1 Role Function-Restrictive Domain Score
[1] [2] Mean (Standard Deviation) Unit of measure: Score on a scale |
||||||
| Number Analyzed | 213 participants | 212 participants | 222 participants | 222 participants | 869 participants | |
| 46.8 (19.67) | 44.9 (21.37) | 44.0 (19.61) | 46.8 (20.36) | 45.6 (20.26) | ||
|
[1]
Measure Description: Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) is 14-item questionnaire to measure health-related quality-of-life impairments attributed to migraine, divided in 3 domains: role function-restrictive: how migraines limit daily social and work-related activities; role function-preventive: how migraines prevent these activities; and emotional function domain: emotions associated with migraines, using a 6-point scale, 1=none of the time and 6=all of the time. Domain scores were rescaled from 0 to 100, with higher scores indicating better migraine specific quality of life.
[2]
Measure Analysis Population Description: mITT Population included 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 post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Number analyzed is the number of participants available for the analyses at Baseline.
|
||||||
|
Daily Activities Domain Score of the Activity Impairment in Migraine- Diary (AIM-D)
[1] [2] Mean (Standard Deviation) Unit of measure: Score on a scale |
||||||
| Number Analyzed | 188 participants | 191 participants | 188 participants | 192 participants | 759 participants | |
| 15.2 (8.25) | 15.5 (8.85) | 16.9 (8.02) | 15.9 (8.34) | 15.9 (8.38) | ||
|
[1]
Measure Description: AIM-D is a 9-item PRO measure that assesses the impact of migraine on performance of daily activities and physical impairment 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 scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine. Baseline was defined as the monthly (averaged for a month) scores during the last 28 days.
[2]
Measure Analysis Population Description: mITT Population included 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 post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Number analyzed is the number of participants available for the analyses at Baseline.
|
||||||
|
Monthly Physical Impairment Domain Score of the AIM-D
[1] [2] Mean (Standard Deviation) Unit of measure: Score on a scale |
||||||
| Number Analyzed | 188 participants | 191 participants | 188 participants | 192 participants | 759 participants | |
| 11.2 (8.11) | 11.7 (8.46) | 13.0 (8.00) | 11.6 (7.85) | 11.9 (8.12) | ||
|
[1]
Measure Description: AIM-D is a 9-item PRO measure that assesses the impact of migraine on performance of daily activities and physical impairment 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 scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine. Baseline was defined as the monthly (averaged for a month) scores during the last 28 days.
[2]
Measure Analysis Population Description: mITT Population included 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 post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Number analyzed is the number of participants available for the analyses at Baseline.
|
||||||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
| Name/Title: | Therapeutic Area, Head |
| Organization: | Allergan |
| Phone: | 714-246-4500 |
| EMail: | clinicaltrials@allergan.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT03777059 |
| Other Study ID Numbers: |
3101-301-002 |
| First Submitted: | December 13, 2018 |
| First Posted: | December 17, 2018 |
| Results First Submitted: | June 18, 2021 |
| Results First Posted: | July 9, 2021 |
| Last Update Posted: | July 9, 2021 |