Trial Outcomes & Findings for Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants (NCT NCT04492020)
NCT ID: NCT04492020
Last Updated: 2023-05-31
Results Overview
The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
518 participants
Primary outcome timeframe
24 hours after taking double-blind study intervention during the prodrome
Results posted on
2023-05-31
Participant Flow
Participant milestones
| Measure |
Treatment Sequence A
Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
Treatment Sequence B
Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
|---|---|---|
|
Overall Study
STARTED
|
264
|
254
|
|
Overall Study
Safety Population
|
247
|
233
|
|
Overall Study
COMPLETED
|
223
|
215
|
|
Overall Study
NOT COMPLETED
|
41
|
39
|
Reasons for withdrawal
| Measure |
Treatment Sequence A
Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
Treatment Sequence B
Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Protocol Violation
|
5
|
2
|
|
Overall Study
Lack of Qualifying Event
|
25
|
27
|
|
Overall Study
Non-compliance with Study Drug
|
2
|
1
|
Baseline Characteristics
Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
Baseline characteristics by cohort
| Measure |
Treatment Sequence A
n=247 Participants
Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
Treatment Sequence B
n=233 Participants
Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 12.63 • n=99 Participants
|
42.9 years
STANDARD_DEVIATION 13.10 • n=107 Participants
|
42.3 years
STANDARD_DEVIATION 12.86 • n=206 Participants
|
|
Age, Customized
< 20
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Customized
20 - 29
|
42 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Customized
30 - 39
|
62 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Age, Customized
40 - 49
|
68 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Age, Customized
50 - 59
|
48 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Age, Customized
60 - 69
|
18 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Customized
>= 70
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=99 Participants
|
205 Participants
n=107 Participants
|
421 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
229 Participants
n=99 Participants
|
216 Participants
n=107 Participants
|
445 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
214 Participants
n=99 Participants
|
209 Participants
n=107 Participants
|
423 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hours after taking double-blind study intervention during the prodromePopulation: The Modified Intent-to-Treat (mITT) population consists of all randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period
The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
Outcome measures
| Measure |
Placebo
n=423 Participants
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
Ubrogepant 100 mg
n=418 Participants
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
|---|---|---|
|
Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose
|
121 Participants
|
190 Participants
|
SECONDARY outcome
Timeframe: 48 hours after taking double-blind study intervention during the prodromePopulation: The Modified Intent-to-Treat (mITT) population consists of all randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period
The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache
Outcome measures
| Measure |
Placebo
n=407 Participants
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
Ubrogepant 100 mg
n=391 Participants
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
|---|---|---|
|
Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose
|
100 Participants
|
159 Participants
|
SECONDARY outcome
Timeframe: 24 hours after taking double-blind study intervention during the prodromePopulation: Modified Intent-to-Treat Population (randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period) with non-missing ability to function normally assessment at each timepoint after dose.
The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome
Outcome measures
| Measure |
Placebo
n=449 Participants
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
Ubrogepant 100 mg
n=448 Participants
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
|---|---|---|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
4 Hours · Responder
|
173 Participants
|
245 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
4 Hours · Nonresponder
|
244 Participants
|
170 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
6 Hours · Responder
|
210 Participants
|
266 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
6 Hours · Nonresponder
|
190 Participants
|
129 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
8 Hours · Responder
|
239 Participants
|
291 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
8 Hours · Nonresponder
|
155 Participants
|
97 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
24 Hours · Responder
|
342 Participants
|
367 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
24 Hours · Nonresponder
|
62 Participants
|
46 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
1 Hour · Responder
|
96 Participants
|
107 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
1 Hour · Nonresponder
|
336 Participants
|
311 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
2 Hours · Responder
|
110 Participants
|
156 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
2 Hours · Nonresponder
|
311 Participants
|
266 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
3 Hours · Responder
|
150 Participants
|
199 Participants
|
|
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
3 Hours · Nonresponder
|
269 Participants
|
213 Participants
|
SECONDARY outcome
Timeframe: 24 hours after taking double-blind study intervention during the prodromePopulation: The Modified Intent-to-Treat (mITT) population consists of all randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period
The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
Outcome measures
| Measure |
Placebo
n=439 Participants
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
Ubrogepant 100 mg
n=434 Participants
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
|---|---|---|
|
Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose
|
61 Participants
|
103 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Ubrogepant 100 mg
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=462 participants at risk
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
Ubrogepant 100 mg
n=456 participants at risk
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.22%
1/462 • Number of events 1 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
|
0.00%
0/456 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
|
Other adverse events
| Measure |
Placebo
n=462 participants at risk
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
Ubrogepant 100 mg
n=456 participants at risk
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
|
|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
3.7%
17/462 • Number of events 17 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
|
5.3%
24/456 • Number of events 25 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
|
|
General disorders
FATIGUE
|
1.5%
7/462 • Number of events 7 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
|
2.6%
12/456 • Number of events 12 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
|
|
Nervous system disorders
DIZZINESS
|
3.0%
14/462 • Number of events 14 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
|
2.4%
11/456 • Number of events 11 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
|
|
Nervous system disorders
SOMNOLENCE
|
1.1%
5/462 • Number of events 5 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
|
2.4%
11/456 • Number of events 11 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place